Application is approved as submitted.
This is a Complete Response letter from the FDA regarding CooperSurgical, Inc.'s supplemental New Drug Application (sNDA) for Paragard (intrauterine copper contraceptive), specifically for a new inserter. The application cannot be approved in its current form due to an incomplete facility inspection and numerous deficiencies identified in prescribing information, carton and container labeling, and the placement guide. The letter outlines detailed recommendations and requirements for resubmission, including a comprehensive safety update.
The FDA issued a 'not approvable' letter for New Drug Application (NDA) 21-164 for Gepirone Hydrochloride Extended Release tablets, citing a lack of substantial evidence for its effectiveness in treating major depressive disorder (MDD) and several Chemistry, Manufacturing, and Controls (CMC) deficiencies. The agency found that only 2 out of 12 studies showed a significant effect, with active comparators often outperforming gepirone ER, and a meta-analysis of the failed studies showed no significant effect. Additionally, the longer-term maintenance efficacy trial yielded negative results, and the applicant's post-hoc attempt to repair it was deemed invalid. The FDA also noted deficiencies in impurity acceptance criteria and stability data.
The FDA issued a 'not approvable' letter for Kyowa Pharmaceutical, Inc.'s New Drug Application (NDA 22-075) for istradefylline tablets (20mg, 40mg) due to inadequate information. The deficiencies cited include insufficient clinical evidence of meaningful benefit beyond a modest effect on 'OFF time' in Parkinson's Disease, required Phase 4 clinical pharmacology commitments, and incomplete nonclinical data regarding brain mineralization.
This document is a Complete Response Letter from the FDA to Mallinckrodt Hospital Products IP Limited regarding New Drug Application (NDA) 022231 for Terlivaz (terlipressin) 1 mg injection. The FDA has determined that the application cannot be approved in its current form due to concerns about the risk-benefit profile, particularly regarding the incidence of serious adverse events like respiratory failure, and unresolved questions about the clinical significance of the primary endpoint. The letter outlines specific deficiencies and required actions for resubmission.
This is a Complete Response letter from the FDA to Cyclomedica Australia Pty Ltd. regarding their New Drug Application (NDA) for Technegas™ Technetium Tc-99m carbon aerosol. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across product quality (drug substance, drug product, process, device) and clinical aspects, and provides recommendations for addressing these issues.
This is a Complete Response letter from the FDA to Cadence Pharmaceuticals regarding their New Drug Application (NDA) for Ofirmev (acetaminophen) Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, labeling, and the need for a comprehensive safety update.
The FDA issued a Complete Response letter for Ferring Pharmaceuticals Inc.'s New Drug Application (NDA 022517) for Nocdurna (desmopressin) Orally Disintegrating Tablets. The application cannot be approved in its current form due to insufficient evidence that the drug's effect on nocturnal voids is clinically meaningful and outweighs the risks of hyponatremia. The FDA recommends conducting a new clinical trial to demonstrate meaningful clinical benefit using patient-reported outcomes and to prospectively evaluate hyponatremia monitoring strategies. The letter also outlines requirements for updating prescribing information, resubmitting the proprietary name, and providing a comprehensive safety update, including data from all nonclinical and clinical studies.
The FDA issued a Complete Response letter for NDA 022561 for cladribine tablets, indicating that the application cannot be approved in its current form. While cladribine was found effective for relapsing remitting multiple sclerosis (RRMS), significant safety concerns, particularly an increased risk of malignancy and lymphopenia, outweigh its benefits. The letter details specific deficiencies in clinical safety data, product quality, and labeling, requiring the applicant to provide additional analyses, studies, and information before resubmission.
This is a Complete Response letter from the FDA to Amgen, Inc. regarding Biologics License Application (BLA) 125522/Original 2 for Repatha (evolocumab). The FDA has determined that the application cannot be approved in its present form due to insufficient clinical data for the proposed 420 mg every two weeks dosing regimen for homozygous familial hypercholesterolemia (HoFH). The letter outlines specific deficiencies and provides recommendations for resubmission, including requirements for additional clinical data, a comprehensive safety update, and labeling revisions.
The document comprises multiple "Complete Response" letters from the FDA to Sun Pharma regarding New Drug Application (NDA) 204417 for Elepsia XR (levetiracetam) extended-release tablets. The letters consistently state that the application cannot be approved in its current form due to unresolved manufacturing facility deficiencies, issues with prescribing information (dosing, format, and content), and, in an earlier letter, concerns regarding bioequivalence data in the fed state and the similarity of plasma concentration-time curves compared to the reference listed drug.
This document is a Complete Response Letter from the FDA to ELC Group regarding New Drug Application (NDA) 205054 for Lutrate®Depot (leuprolide acetate for injection). The FDA has determined that the application cannot be approved in its present form due to deficiencies in clinical/statistical data, product quality, regulatory compliance, prescribing information, proprietary name, facility inspections, and safety update requirements.
The FDA issued two Complete Response letters for New Drug Application (NDA) 208574 for Romidepsin Injection, indicating that the application cannot be approved in its present form. The letters cite deficiencies related to manufacturing facilities (Teva Parenteral Medicines, Inc. and Teva Pharmaceutical Works Private Limited Company), product quality, and require comprehensive safety updates and revisions to prescribing information.
This is a Complete Response Letter from the FDA to AcelRx Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 209128 for DSUVIA (sufentanil sublingual tablet). The FDA has determined that the application cannot be approved in its present form due to deficiencies related to safety, human factors, prescribing information, proprietary name, Risk Evaluation and Mitigation Strategy (REMS), safety update requirements, and container/carton labeling.
This is a Complete Response letter from the FDA regarding New Drug Application (NDA) 211150/Original 2 for Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. The FDA has determined that the application cannot be approved in its present form due to a lack of substantial evidence of effectiveness, citing inadequacies in the submitted clinical trials (HARMONY I and HARMONY CTP). The letter outlines the specific deficiencies and provides a path forward, including the requirement for an additional randomized, double-blind, placebo-controlled study.
This letter from the FDA identifies deficiencies in NDA 212097/S-012, specifically regarding dose accuracy testing, chemistry, manufacturing, and controls (CMC) for IV administration, prescribing information, proprietary name resubmission, and a comprehensive safety update. The applicant is required to address these deficiencies within one year to avoid withdrawal of the application.
This is a Complete Response Letter from the FDA to Therakind Limited regarding New Drug Application (NDA) 212479 for Jylamvo (methotrexate) oral solution. The FDA has determined that the application cannot be approved in its present form due to product quality issues related to a manufacturing facility and deficiencies in labeling and safety update submissions.
This FDA letter communicates deficiencies and requirements for the approval of New Drug Application (NDA) 212782. It addresses issues related to prescribing information, carton and container labeling, manufacturing facility inspections, product quality, and safety updates, requiring the applicant to submit a comprehensive response within one year.
The FDA issued Complete Response letters for New Drug Applications (NDAs) 212887 (VOCABRIA) and 212888 (CABENUVA) from ViiV Healthcare Company, indicating that neither application can be approved in its current form due to various deficiencies. Approval of VOCABRIA is contingent on CABENUVA's approval.
This is a Complete Response letter from the FDA to AVEO Pharmaceuticals, Inc. regarding their New Drug Application (NDA 204408) for tivozanib hydrochloride capsules. The FDA has determined that the application cannot be approved in its current form due to deficiencies in clinical data (inconsistent progression-free survival and overall survival results, uninterpretable trial results), product quality (unsupported dissolution acceptance criterion), and pending labeling review. The letter outlines specific recommendations and requirements for addressing these issues for a potential resubmission.
This is a Complete Response Letter from the FDA to Alkermes, Inc. regarding New Drug Application (NDA) 213378 for Lybalvi (olanzapine and samidorphan). The FDA has determined that the application cannot be approved in its present form due to objectionable conditions at a manufacturing facility, pending review of prescribing information, and outstanding clinical data requirements.
This document is a Complete Response letter from the FDA to Genentech, Incorporated, regarding their New Drug Applications (NDAs) and supplemental NDAs (sNDAs) for XOFLUZA (baloxavir marboxil) for the treatment and post-exposure prophylaxis of influenza in pediatric patients. The FDA determined that the applications cannot be approved in their present form due to concerns primarily related to the high frequency of treatment-emergent resistance in pediatric patients and the potential risk of transmission of resistant virus.
This document is a Complete Response letter from the FDA to Gilead Sciences, Inc. regarding their New Drug Applications (NDAs) for lenacapavir injection (NDA 215973) and lenacapavir tablet (NDA 215974). The FDA has determined that the applications cannot be approved in their current form due to various deficiencies related to product quality, prescribing information, proprietary name, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.
This document is a deficiency letter from the FDA regarding New Drug Application (NDA) 216190, outlining specific deficiencies related to prescribing information, carton and container labeling, proprietary name, and a comprehensive safety update. It also details the process for resubmission or other actions, including potential withdrawal if no action is taken within one year.
The FDA issued a Complete Response letter for NDA 217186 for Crexont (carbidopa and levodopa) Extended Release Capsules, indicating that the application cannot be approved in its current form due to insufficient scientific bridging for carbidopa pharmacokinetic exposure and inadequate long-term safety data.
This is a Complete Response letter from the FDA to Astellas Pharma US, Inc. regarding their supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution). The FDA has determined that the application cannot be approved in its present form due to insufficient data supporting an expanded dosing regimen and outlines deficiencies and recommendations for resubmission.
The FDA issued a Complete Response letter for Azurity Pharmaceuticals, Inc.'s New Drug Application (NDA) 219122 for sitagliptin oral solution, indicating that the application cannot be approved in its current form due to outstanding deficiencies related to facility inspections, prescribing information, proprietary name, and safety updates.
This is a Complete Response letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) 761215/Original 2 for Rezvoglar (insulin glargine-aglr) injection, seeking interchangeability with U.S.-licensed Lantus. The FDA has determined that the application cannot be approved in its present form, primarily due to the unexpired exclusivity period for a prior interchangeable biological product. The letter outlines regulatory reasons for non-approval, reserves comment on labeling, and details requirements for a safety update if the application is resubmitted.
This is a Complete Response Letter from the FDA to Citius Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) for Lymphir (denileukin diftitox-cxdl) for injection. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies and recommendations that must be addressed.
The FDA has issued a provisional determination for BLA 761338/Original 2 for Steqeyma (ustekinumab-stba) injection, finding it meets the interchangeability criteria with Stelara (ustekinumab). However, approval cannot be granted at this time due to unexpired exclusivity for the first interchangeable biosimilar biological products. The letter outlines deficiencies related to labeling, safety updates, and product quality (stability and compatibility studies), and provides instructions for resubmission to obtain eventual approval.
This letter from the FDA outlines deficiencies in a Biologics License Application (BLA 761367) and provides specific requirements for resubmission. It covers various aspects including filling capability data, prescribing information, proprietary name, safety updates, microbiology, product quality, and device performance, emphasizing the need for comprehensive data and adherence to regulatory standards for approval.
The FDA has issued a provisional determination that Pyzchiva (ustekinumab-ttwe) is interchangeable with Stelara (ustekinumab) for various formulations, but cannot approve the applications (BLA 761373/Original 2 and BLA 761425/Original 2) due to an unexpired period of exclusivity for the first interchangeable biosimilar biological products. The letter outlines the steps required for future approval once the exclusivity period expires, including submitting an amendment with updated information and fulfilling postmarketing commitments.
This is a Complete Response letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) 761215/Original 2 for Rezvoglar (insulin glargine-aglr) injection, seeking interchangeability with U.S.-licensed Lantus. The FDA cannot approve the application in its current form primarily because the regulatory exclusivity period for the reference product has not yet expired, as stipulated by section 351(k)(6) of the Public Health Service Act. The letter also outlines specific requirements for a comprehensive safety update, potential labeling revisions, and the necessary next steps for resubmission or other actions.
This document comprises two FDA Complete Response Letters (CRLs) issued to Laboratorios Farmacéuticos ROVI, S.A. for their New Drug Application (NDA) 214835 for Risvan (risperidone ISM) intramuscular injectable suspension. The letters state that the application cannot be approved in its current form due to various deficiencies related to facility inspections, product quality, human factors, and prescribing information.
The FDA issued a Complete Response Letter for NDA 214697 for Neffy (epinephrine nasal spray), indicating that the application cannot be approved in its current form due to deficiencies in clinical/clinical pharmacology, product quality (nitrosamines), and requiring a comprehensive safety update, among other items.
The FDA issued a Complete Response letter for New Drug Application (NDA) 214759 for Grafapex (treosulfan) for injection, indicating that the application cannot be approved in its current form due to several deficiencies related to clinical/statistical data, prescribing information, proprietary name, safety update, and nonclinical data.
This document is a Complete Response letter from the FDA to AbbVie Inc. regarding their New Drug Application (NDA) 216962 for Vyalev (foscarbidopa and foslevodopa) injection and delivery system. The FDA has determined that the application cannot be approved in its current form due to deficiencies related to facility inspections, prescribing information, carton/container labeling, safety update requirements, and instructions for use for the associated delivery system (Vyafuser). The letter outlines specific reasons for non-approval and provides recommendations for addressing these issues.
This FDA letter, an 'Other Action Letter' for NDA 218772, informs the applicant of outstanding product quality deficiencies and outlines requirements for resubmission. It reserves comments on draft labeling and carton/container labeling until the application is otherwise approvable/adequate. The letter also addresses the proprietary name, Arbli, which is conditionally acceptable, and provides detailed instructions for a mandatory safety update to be included with the resubmission. The applicant is required to resubmit or take other actions within one year, fully addressing all identified deficiencies, and is reminded that the product cannot be legally marketed until approved.
This document is a Complete Response letter from the FDA to Tanvex BioPharma USA, Inc. for their Biologics License Application (BLA) 761126 for TX01. The FDA has determined that the application cannot be approved in its present form due to unresolved deficiencies related to facility inspections, comparative analytical assessment data, and requirements for labeling, proprietary name resubmission, and safety updates.
This is a Complete Response letter from the FDA to Akeso Biopharma Co., Ltd. regarding their Biologics License Application (BLA) for AK105 (penpulimab-kcqx). The FDA has determined that the application cannot be approved in its present form due to clinical, quality, labeling, and facility inspection deficiencies, and provides recommendations for addressing these issues.
This document is a Complete Response Letter from the FDA to Checkpoint Therapeutics, Incorporated, for their Biologics License Application (BLA) 761297 for cosibelimab (CK-301). The FDA has determined that the application cannot be approved in its present form due to unresolved facility inspection deficiencies at Samsung Biologics Co., Ltd., and concerns regarding the reliability of data generated at that facility, which impact the manufacturing process validation and characterization.
This is a Complete Response Letter from the FDA to Novo Nordisk regarding Biologics License Application (BLA) 761315 for NNC0172-2021 injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies identified in clinical and clinical pharmacology, device validation, product quality, and facility inspection.
This is a Complete Response Letter from the FDA to Delcath Systems, Incorporated, for their New Drug Application (NDA) 201848 for Melblez Kit. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to clinical effectiveness, clinical pharmacology, and product quality. Key issues include a lack of substantial evidence of effectiveness where benefits outweigh risks, insufficient pharmacokinetic characterization for the proposed commercial product, and an inadequate toxicological risk assessment of leachables and extractables from the device components of the commercial configuration.
The FDA issued two Complete Response Letters for NDA 204311 for Abacavir and Lamivudine Tablets for Oral Suspension, indicating that the application cannot be approved in its current form. The primary reasons for non-approval include unresolved deficiencies from facility inspections at Mylan Laboratories Limited Unit-8 and requirements for revisions to prescribing information, carton/container labeling, and the medication guide. The letters provide detailed instructions for addressing these issues and for resubmitting the application.
This document is a Complete Response letter from the FDA to AFT Pharmaceuticals, Ltd. regarding New Drug Application (NDA) 209471 for COMBOGESIC. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical, statistical, nonclinical, product quality, and facility inspection areas. The letter outlines specific requirements for revising labeling, providing safety updates, addressing data quality issues, justifying drug substance specifications, analyzing elemental impurities, and confirming process validation. It also details the process and timeline for resubmission or other actions.
This is a Complete Response letter from the FDA to Braeburn Inc. for their New Drug Application (NDA) 210136 for BRIXADI (buprenorphine) extended-release injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name resubmission, safety update requirements, and mandated postmarketing studies.
The FDA issued a Complete Response letter for New Drug Application (NDA) 210852 for Cyclophosphamide Injection, indicating that the application cannot be approved in its current form due to deficiencies related to facility inspections and requiring a comprehensive safety update.
The FDA issued a Complete Response letter for NDA 211413 for Cefazolin for Injection USP, indicating non-approval due to deficiencies primarily related to the inadequate safety qualification of identified leachables and incomplete safety updates. The letter provides specific recommendations for addressing these issues and outlines the process for resubmission or further action.
This document contains two FDA letters concerning NDA 211566 for Sitagliptin Tablets. The first letter, dated March 3, 2023, details extensive requirements for updating safety data in a resubmission, including incorporating new clinical trial data, comparing adverse event frequencies, providing worldwide safety experience, and translating foreign labeling. It mandates resubmission or other actions within one year. The second letter, dated September 2, 2021, grants tentative approval for Sitagliptin Tablets for type 2 diabetes, contingent on the resolution of patent protection and exclusivity issues, specifically a patent infringement suit related to a Paragraph IV certification. It outlines the conditions for lifting the 30-month stay and the process for requesting final approval, which includes a safety update and confirmation of any changes to the application's conditions.
The FDA issued a Complete Response letter for NDA 212849 for Rykindo (risperidone) for extended-release injectable suspension, indicating that the application cannot be approved in its present form. The FDA identified deficiencies primarily related to clinical and clinical pharmacology concerns regarding unexplained concentration spikes and potential dose dumping, disagreeing with the applicant's root-cause analysis. Additional deficiencies include biopharmaceutics issues, pending labeling comments, and the need for a comprehensive safety update.
This document is a Complete Response Letter (CRL) from the FDA to Verrica Pharmaceuticals Inc. for New Drug Application (NDA) 212905, indicating that the application for cantharidin topical solution, 7% cannot be approved in its present form. It outlines specific deficiencies and provides detailed instructions for resubmission, focusing on updated labeling, proprietary name resubmission, and a comprehensive safety update.
This is a Complete Response Letter from the FDA to Teva Neuroscience, Inc. regarding New Drug Application (NDA) 213586 for risperidone extended-release injectable suspension. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to clinical data quality, syringe and carton labeling, and proprietary name submission. The letter outlines specific reasons for non-approval and provides recommendations for addressing these issues, including requirements for a safety update and options for resubmission or further action.
This is a Complete Response Letter from the FDA to Ardelyx, Inc. regarding their New Drug Application (NDA) for tenapanor hydrochloride tablets. The FDA has determined that the application cannot be approved in its present form due to insufficient evidence of a clinically relevant treatment effect on serum phosphorus, despite acknowledging the drug's efficacy in reducing serum phosphorus. The letter outlines specific deficiencies and requirements for resubmission.
The FDA issued a Complete Response letter for NDA 213972 for sulopenem etzadroxil and probenecid tablets, indicating that the application cannot be approved in its current form due to a lack of substantial evidence of effectiveness from clinical trials and other deficiencies related to labeling, barcodes, safety updates, and nonclinical PK/PD studies.
This is a Complete Response letter from the FDA to Takeda Pharmaceuticals U.S.A., Inc. for their New Drug Application (NDA) 213976 for Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). The FDA determined that the application cannot be approved in its current form due to insufficient evidence of effectiveness, citing deficiencies in clinical and statistical data, and provides recommendations for resolution.
The FDA issued a Complete Response letter for NDA 214927 for arimoclomol capsules, indicating that the application cannot be approved in its present form due to a lack of substantial evidence of effectiveness. Key concerns include issues with the 5-domain NPC Clinical Severity Scale (5DNPCCSS) as a primary endpoint, the statistical analysis (hypothetical estimand vs. while-on-treatment estimand), and weak/contradictory confirmatory evidence from in vitro and animal studies.
This document is a Complete Response letter from the FDA to CMP Development LLC regarding their New Drug Application (NDA) for sildenafil oral suspension, 10 mg/ml. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name, and safety updates.
This is a Complete Response Letter from the FDA to Galephar Pharmaceutical Research Inc. regarding their New Drug Application (NDA) 215040 for Legubeti (acetylcysteine) for oral solution. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to clinical data, regulatory compliance, and safety information.
The FDA issued a Complete Response letter for NDA 215064 for Filsuvez (birch triterpenes) gel, indicating that the application cannot be approved in its current form due to insufficient evidence of effectiveness for the proposed indication of treating wounds associated with inherited epidermolysis bullosa (EB). The letter details specific deficiencies in clinical data and outlines requirements for a safety update and other submissions.
This document is an 'Other Action Letter' from the FDA to an applicant regarding New Drug Application (NDA) 215151. It outlines deficiencies and required actions for the applicant to address within one year to move the application towards approval. Key areas of focus include labeling updates, proprietary name resubmission, and a comprehensive safety update.
The FDA issued a Complete Response Letter for Akebia Therapeutics, Inc.'s New Drug Application (NDA) 215192 for vadadustat tablets. The application was not approved in its current form due to an unfavorable benefit-risk assessment, citing major safety concerns including major adverse cardiac events (MACE), thromboembolic events, and drug-induced liver injury (DILI), which were deemed to outweigh the benefits for the proposed indication of anemia associated with chronic kidney disease (CKD) in adults not on dialysis and on dialysis.
The FDA issued a Complete Response letter for Shilpa Medicare Limited's New Drug Application (NDA 215179) for Pemetrexed Injection, indicating that the application cannot be approved in its current form due to unresolved product quality issues, facility inspection deficiencies, and outstanding safety update requirements. The letter outlines specific actions and data submissions required for potential approval.
The FDA issued a Complete Response Letter for NDA 215212 for Meropenem for Injection 2 g/vial, indicating that the application cannot be approved in its current form due to deficiencies in nonclinical, product quality, and safety update sections. The letter outlines specific issues and provides recommendations for resolution, requiring the applicant to address all deficiencies within one year for resubmission.
This is a Complete Response Letter from the FDA to AFT Pharmaceuticals Ltd. regarding their New Drug Application (NDA) 215320 for Combogesic (acetaminophen/ibuprofen) solution for injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to nonclinical data (toxicological risk assessment for leachables), prescribing information, carton and container labeling, medication guide, proprietary name, and the need for a safety update.
This is a Complete Response letter from the FDA to Braintree Laboratories, Inc. regarding New Drug Application (NDA) 215344 for Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) for oral solution. The FDA has determined that the application cannot be approved in its present form due to product quality/facility inspection deficiencies, issues with prescribing information, carton and container labeling, and the need for a comprehensive safety update.
This is a Complete Response letter from the FDA to Almatica Pharma, LLC, for their New Drug Application (NDA) 215721 for zolpidem tartrate capsules. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, prescribing information, medication guide, and safety updates. The letter outlines specific requirements and recommendations for the applicant to address these issues.
This is a Complete Response letter from the FDA to Liqmeds Worldwide Limited regarding New Drug Application (NDA) 216482 for mycophenolate mofetil oral suspension. The application cannot be approved in its present form primarily due to the lack of a required Risk Evaluation and Mitigation Strategy (REMS). The letter outlines specific deficiencies and provides recommendations for addressing them, including detailed requirements for a safety update and submission procedures.
This is a Complete Response letter from the FDA to Ascendis Pharma Bone Diseases A/S regarding their New Drug Application (NDA) 216490 for palopegteriparatide injection. The FDA has determined that the application cannot be approved in its present form due to unresolved deficiencies related to product quality/device, labeling, and requires specific safety updates and postmarketing studies.
The FDA issued a Complete Response letter for NDA 217202 for landiolol injection, indicating that the application cannot be approved in its current form due to deficiencies related to product quality, manufacturing, prescribing information, proprietary name, and safety updates. The letter also outlines a postmarketing requirement to assess drug transporter inhibition.
This is a Complete Response letter from the FDA to Botanix SB Inc. regarding their New Drug Application (NDA) 217347 for sofpironium bromide. The FDA has determined that the application cannot be approved in its present form due to deficiencies primarily related to human factors study results and the need for a safety update.
The FDA issued a Complete Response letter for Takeda Pharmaceuticals' Biologics License Application (BLA) 761133 for MLN0002 SC, indicating that the application cannot be approved in its current form due to various deficiencies. The letter details specific recommendations across product quality, human factors, labeling (device, carton, container, prescribing information, medication guide), proprietary name, and facility inspections.
This document is a Complete Response Letter from the FDA to Bio-Thera Solutions Ltd. regarding their Biologics License Application (BLA) 761198 for BAT1706. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical pharmacology, product quality, labeling, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.
This is a Complete Response Letter from the FDA to Hugel, Inc. regarding their Biologics License Application (BLA) for letibotulinumtoxinA injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including unresolved facility inspection issues, pending labeling comments, and requirements for a comprehensive safety update.
This letter from the FDA's Center for Drug Evaluation and Research outlines deficiencies in Biologics License Application (BLA) 761248 for Kisunla and provides detailed requirements for a resubmission. Key areas addressed include long-term safety characterization, prescribing information, carton and container labeling, proprietary name, a comprehensive safety update, and product quality specifications. The applicant is required to address all deficiencies within one year to avoid withdrawal of the application.
This is a Complete Response Letter from the FDA to Fresenius Kabi USA, LLC, for their Biologics License Application (BLA) 761275 for MSB11456. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facilities, and requires a comprehensive safety update and other technical revisions before approval.
The FDA issued a Complete Response letter for Biologics License Application (BLA) 761299 for AVT02, indicating that the application cannot be approved in its current form due to deficiencies. The letter outlines specific requirements for resubmission, including resolving facility inspection issues, updating labeling, resubmitting the proprietary name, and providing a comprehensive safety update.
This is a Complete Response Letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) for lebrikizumab injection. The FDA has determined that the application cannot be approved in its present form due to unresolved product quality issues related to manufacturing facility deficiencies, data reliability concerns, and pending labeling and proprietary name reviews. The letter outlines specific deficiencies and provides recommendations for resolution, including a comprehensive safety update.
This is a Complete Response Letter from the FDA to Regeneron Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) 761355 for Eylea HD (aflibercept) Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies in manufacturing facilities and controls, specifically non-compliance with current good manufacturing practice (cGMP) regulations.
The FDA issued a Complete Response letter for Biologics License Application (BLA) 761343 for AVT04, indicating that the application cannot be approved in its present form due to outstanding deficiencies related to facility inspections, labeling, safety updates, product quality, and microbial quality.
This letter from the FDA's Center for Drug Evaluation and Research addresses deficiencies in Biologics License Application (BLA) 761365 for IMAB362 drug product. It outlines specific requirements related to analytical methods, manufacturing, labeling, proprietary name, and a comprehensive safety update, instructing the applicant on necessary actions for potential approval.
The FDA issued a Complete Response letter for New Drug Application (NDA) 205394 for Rizaport (rizatriptan) oral film 10 mg to IntelGenx Corp., indicating that the application cannot be approved in its current form. The letter details significant deficiencies related to drug product stability, manufacturing facility inspections, and various aspects of prescribing information and carton/container labeling that must be addressed.
This document is a Complete Response letter from the FDA to InnoPharma Licensing LLC regarding their New Drug Application (NDA) 206968 for Acetaminophen Injection, 10 mg/mL. The FDA has determined that the application cannot be approved in its present form due to several deficiencies in nonclinical data, prescribing information, carton and container labeling, and the need for a safety update.
The FDA issued a Complete Response letter for Amphastar Pharmaceuticals, Inc.'s New Drug Application (NDA) 208969 for Naloxone Nasal Spray, indicating that the application cannot be approved in its present form due to several deficiencies. These include issues with the human factors validation study, pediatric safety concerns regarding product administration and absorption, unresolved manufacturing facility deficiencies, and the need for a comprehensive safety update. The letter provides recommendations for addressing these issues and outlines the process for resubmission or other actions.
This is a Complete Response letter from the FDA to scPharmaceuticals Services, Inc. for their New Drug Application (NDA) 209988 for Furoscix™ (Furosemide), a drug-device combination product. The FDA has determined that the application cannot be approved in its current form due to significant deficiencies related to device design changes, Master Access File documentation, biocompatibility testing, chemical characterization (leachables), electrical safety and electromagnetic compatibility, labeling, and human factors studies. The letter outlines specific issues and provides recommendations for addressing them.
This is a Complete Response letter from the FDA to Zhejiang Novus Pharmaceuticals Co. Ltd. regarding their New Drug Application (NDA) for Vancomycin Hydrochloride for Injection. The FDA has determined that the application cannot be approved in its present form due to unresolved objectionable conditions at the manufacturing facility, non-conformance of the proposed Prescribing Information with regulations, and a minor error in carton/container labeling. The letter outlines the deficiencies and provides recommendations for addressing them, including a detailed safety update requirement.
This document is an 'Other Action Letter' from the FDA's Center for Drug Evaluation and Research regarding NDA 211363. It outlines several deficiencies and required actions for the applicant to address, including issues with patent certification, prescribing information, and safety updates, before the application can be approved.
This document is a Complete Response Letter from the FDA to Glenmark Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 211746 for GSP 301 (olopatadine HCl and mometasone furoate) 665 mcg/25 mcg Nasal Spray. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to facility inspections, product quality, and requirements for prescribing information and safety updates.
This is a Complete Response Letter from the FDA to Fennec Pharmaceuticals, Inc. for their New Drug Application (NDA) 212937 for PEDMARK (sodium thiosulfate injection). The FDA has determined that the application cannot be approved in its current form due to product quality and safety data deficiencies, and outlines the necessary actions for resubmission.
This document is a Complete Response Letter from the FDA to an applicant for New Drug Application (NDA) 213260, indicating that the application cannot be approved in its current form due to various deficiencies. It outlines the specific issues that need to be addressed before approval can be granted, including manufacturing facility observations, product reformulation, bioequivalence studies, labeling updates, safety updates, and environmental assessment requirements.
This is a Complete Response Letter from the FDA to Azurity Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 213593 for omeprazole and sodium bicarbonate for oral suspension. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, clinical data, and labeling.
This is a Complete Response Letter from the FDA to Azurity Pharmaceuticals, Inc. for New Drug Application (NDA) 214273 for Zonisade (zonisamide) oral suspension. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, carton and container labeling, medication guide, proprietary name, and safety update requirements.
This document is a Complete Response Letter from the FDA to Polarean Inc. regarding their New Drug Application (NDA) 214375 for Xenoview (xenon-129 hyperpolarized) for Inhalation. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality (drug substance, drug product, device design, and reliability), prescribing information, carton and container labeling, proprietary name, and facility inspections. The letter outlines specific issues and provides recommendations for addressing them.
This letter from the FDA's Center for Drug Evaluation and Research informs the applicant of NDA 214522 about required actions following an initial review. It outlines the process for resubmission or other actions, emphasizing the need to address all deficiencies and the consequences of inaction. It also provides guidance on requesting meetings and clarifies that the drug cannot be marketed until approved.
The FDA issued a Complete Response Letter for CorMedix Inc.'s New Drug Application (NDA) 214520 for taurolidine/heparin catheter lock solution. The application cannot be approved in its current form due to deficiencies related to product quality/facility inspections, prescribing information, carton/container labeling, and the proposed proprietary name. The letter outlines specific requirements and recommendations for addressing these issues in a resubmission.
This is a Complete Response letter from the FDA to Acer Therapeutics Inc. regarding their New Drug Application (NDA) 214860 for sodium phenylbutyrate. The FDA has determined that the application cannot be approved in its current form due to several deficiencies, including an incomplete facility inspection, issues with prescribing information and labeling, and requirements for a safety update and additional nonclinical data.
This document is an 'Other Action Letter' from the FDA regarding NDA 215352. It outlines deficiencies and provides guidance on various aspects including human factors validation, prescribing information, carton and container labeling, proprietary name, and safety updates. It also specifies the actions required for resubmission and the timeline for response.
The FDA issued a Complete Response letter for NDA 215559 for palovarotene capsules, indicating that the application cannot be approved in its current form due to inadequate support for efficacy. The letter outlines major unresolved review issues, primarily concerning the efficacy data and analysis methods, and provides detailed recommendations for additional data and analyses required for resubmission.
This is a Complete Response letter from the FDA to Spes Pharmaceuticals Inc. regarding their New Drug Application (NDA) 216686 for fosaprepitant injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies identified in product quality/facility inspections, prescribing information, carton and container labeling, and clinical safety data.
This is a Complete Response letter from the FDA to UCB, Inc. regarding their Biologics License Application (BLA) 761151 for UCB4940 (CDP4940). The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections and product quality. The letter outlines specific requirements for resubmission, including resolving facility inspection deficiencies, resubmitting the proprietary name, and providing a comprehensive safety update.
This document is a Complete Response Letter from the FDA to Chiesi USA regarding their Biologics License Application (BLA) 761161 for PRX-102. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including issues with manufacturing facilities, questions regarding the accelerated approval pathway given the availability of other therapies, non-conformity of proposed Prescribing Information, and requirements for a comprehensive safety update. The letter also notes that an inspection of a manufacturing facility is required but was not possible due to travel restrictions.
This is a Complete Response Letter from the FDA to Provention Bio, Inc. regarding their Biologics License Application (BLA) 761183 for PRV-031. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical pharmacology, product quality, facility inspections, prescribing information, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.
The FDA issued a Complete Response letter for Biologic License Application (BLA) 761184 for MOD-4023 injection, indicating that the application cannot be approved in its present form. The primary reasons for non-approval include concerns regarding immunogenicity, specifically high rates of anti-drug antibody (ADA) formation and potential for cross-reactivity with other human growth hormone (hGH) products, which could lead to attenuation of effectiveness and non-responsiveness to other therapies. The FDA also noted that required facility inspections could not be completed due to travel restrictions. The letter outlines specific recommendations and requirements for the applicant to address these deficiencies.
This is a Complete Response Letter from the FDA to MediWound, Ltd. regarding their Biologics License Application (BLA) 761192 for 'concentrate of proteolytic enzymes enriched in bromelain' gel. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality, clinical study data integrity, and safety information.
This document is an 'Other Action Letter' from the FDA regarding Biosimilar License Application (BLA) 761219. It outlines deficiencies related to prescribing information, carton and container labeling, proprietary name, and safety updates, and also includes specific requirements for device testing. The letter instructs the applicant on necessary actions for resubmission to achieve approval.
The FDA issued a Complete Response Letter for Biologics License Application (BLA) 761240 for toripalimab-tpzi injection, indicating that the application cannot be approved in its current form due to deficiencies primarily related to product quality (viral safety), labeling, and safety update requirements.
This is a Complete Response Letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) 761279 for LY3074828 injection for ulcerative colitis. The FDA has determined that the application cannot be approved in its current form due to deficiencies related to facility inspections, prescribing information, and the need for a comprehensive safety update.
The FDA issued a Complete Response letter for DURECT Corporation's New Drug Application (NDA) 204803 for POSIMIR (bupivacaine extended-release solution), indicating that the application cannot be approved in its current form. The primary reasons for non-approval are insufficient clinical data to demonstrate the safety of POSIMIR, specifically regarding adverse events related to shoulder joints, skin/underlying tissues (bruising, hematoma, pruritus, dehiscence), and neurologically related adverse events (dizziness, dysgeusia, headache, hypoesthesia, paresthesia, somnolence). The letter outlines specific additional studies required to characterize the risk profile and details requirements for a comprehensive safety update.
This is a Complete Response letter from the FDA to Hospira, Inc. regarding their New Drug Application (NDA) 210282 for Daptomycin for Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, product quality (elemental impurities), and prescribing information. The letter outlines specific requirements for addressing these issues, including a comprehensive safety update, and provides instructions for resubmission or other actions.
The FDA issued a Complete Response letter for New Drug Application (NDA) 210526 for Dyanavel XR (amphetamine) extended-release tablets, indicating that the application cannot be approved in its current form. The letter outlines deficiencies related to manufacturing facility inspections, prescribing information, medication guide requirements, proprietary name resubmission, and the need for a comprehensive safety update.
The FDA issued a Complete Response letter for AuroMedics Pharma LLC's New Drug Application (NDA) 210735 for Cyclophosphamide Injection, indicating that the application cannot be approved in its current form due to several deficiencies. These deficiencies include unresolved issues from a facility inspection, non-conformance of proposed Prescribing Information (PI) with regulatory requirements, and incomplete safety update information.
This is a Complete Response letter from the FDA to Clearside Biomedical, Inc. regarding their New Drug Application (NDA) 211950 for XIPERE (triamcinolone acetonide ophthalmic suspension). The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to manufacturing, product safety data, process robustness, and compliance with patent certification regulations.
This document is a Complete Response Letter from the FDA to Heron Therapeutics, Inc. regarding their New Drug Application (NDA) 211988 for Zynrelef. The FDA has determined that the application cannot be approved in its present form due to several nonclinical and other deficiencies, and provides recommendations for addressing these issues.
This letter from the FDA's Center for Drug Evaluation and Research outlines deficiencies found in New Drug Application (NDA) 212304. It provides specific instructions for revisions to labeling, packaging, and submission content, including a comprehensive safety update, to address these deficiencies.
This document is a Complete Response letter from the FDA to Adamis Pharmaceuticals Corporation regarding their New Drug Application (NDA) for Naloxone HCl Injection, 5 mg/0.5 mL. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to clinical data, device design, risk analysis, human factors, and statistical validation of manufacturing processes and device performance.
This letter from the FDA's Center for Drug Evaluation and Research addresses an applicant regarding deficiencies in application number 213218Orig1s000. It requests the submission of draft carton and container labeling, resubmission of the proposed proprietary name, and a comprehensive safety update. The safety update must include detailed new safety data from clinical studies, comparisons with original data, retabulation of trial discontinuations, case report forms for adverse events, updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. The applicant is required to resubmit or take other actions within one year, fully addressing all deficiencies, or the application may be considered withdrawn. The drug cannot be marketed until approved.
This is a Complete Response Letter from the FDA to Esteve Pharmaceuticals, S.A. regarding their New Drug Application (NDA) 213426 for celecoxib and tramadol hydrochloride tablets. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name resubmission, Risk Evaluation and Mitigation Strategy (REMS) requirements, and safety updates.
This letter from the FDA addresses the New Drug Application (NDA) 213478, outlining deficiencies that prevent its approval. It provides instructions regarding labeling, proprietary name resubmission, facility inspection requirements (specifically for TOYO PHARMACEUTICAL CO. LTD. in Japan, which was delayed due to travel restrictions), and a comprehensive safety update. The applicant is required to address these deficiencies within one year, with specific guidance on resubmission and the option to request a meeting.
The FDA issued a Complete Response letter for New Drug Application (NDA) 213645 for DAPZURA RT (daptomycin) for Injection, indicating that the application cannot be approved in its present form. The primary reasons for non-approval include inadequate non-clinical safety qualification for several detected leachables, deficiencies in the proposed Prescribing Information and carton/container labeling, and the need for a comprehensive safety update.
This is a Complete Response Letter from the FDA to Xellia Pharmaceuticals, ApS, for their New Drug Application (NDA) 213895 for Vancomycin Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, nonclinical toxicology, and safety updates. The letter outlines specific issues and recommendations for addressing them.
The FDA issued a Complete Response Letter for New Drug Application (NDA) 213953 for testosterone undecanoate, citing that the application cannot be approved in its present form due to unreliable pharmacokinetic (PK) data from the pivotal efficacy and safety trial (MRS-TU-2019EXT). The unreliability stems from inadequate documentation of PK sample handling and processing at multiple clinical sites, which raised significant uncertainties about the integrity of the entire study's PK data.
This is a Complete Response Letter from the FDA to Novartis Pharmaceuticals Corporation regarding New Drug Application (NDA) 214012 for inclisiran injection. The FDA has determined that the application cannot be approved in its present form due to objectionable conditions noted during a review of records at a manufacturing facility and other outstanding issues.
This is a Complete Response Letter from the FDA to United Therapeutics Corp. regarding their New Drug Application (NDA) 214324 for treprostinil inhalation powder. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name resubmission, and the need for a comprehensive safety update.
This is a Complete Response Letter from the FDA to CMP Development LLC regarding their New Drug Application (NDA) for NORLIQVA (amlodipine) Oral Solution 1 mg/mL. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, proprietary name resubmission, and required safety updates.
This is a Complete Response Letter from the FDA to Novitium Pharma LLC regarding their New Drug Application (NDA) 214581 for Hydroxychloroquine Sulfate Tablets. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies and recommendations.
This is a Complete Response letter from the FDA to Nevakar, Inc. for their New Drug Application (NDA) 214628 for Norepinephrine Bitartrate in Sodium Chloride Injection. The FDA has determined that the application cannot be approved in its present form due to unresolved facility inspection deficiencies, additional CMC deficiencies, and requirements for a comprehensive safety update.
This document is a Complete Response letter from the FDA to Accord Healthcare, Inc. regarding their New Drug Application (NDA) 215000 for Carmustine for injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, prescribing information, and safety updates. The letter outlines specific actions required for resubmission.
This is a Complete Response letter from the FDA to Santen, Inc. regarding their New Drug Application (NDA) for Omlonti (omidenepag isopropyl ophthalmic solution), 0.002%. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including manufacturing facility issues, inadequate clinical safety data regarding corneal endothelial cell loss, and requirements related to the product's classification as a drug-led combination product. The letter outlines specific actions and information required for resubmission and potential approval.
The FDA issued a Complete Response Letter for Biologics License Application (BLA) 761082 for Theragrastim, indicating that the application cannot be approved in its current form due to several deficiencies, including the need for a facility inspection, issues with stability protocols and analytical methods, and requirements for labeling and safety updates.
This is a Complete Response Letter from the FDA to Kashiv BioSciences, LLC regarding their Biologics License Application (BLA) 761084 for TPI-120. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across microbiology, labeling, facility inspections, safety data, stability, shipping validation, and immunogenicity.
This is a Complete Response Letter from the FDA to Revance Therapeutics, Inc. regarding their Biologics License Application (BLA) 761127 for daxibotulinumtoxinA for injection. The FDA has determined that the application cannot be approved in its present form due to unresolved manufacturing facility deficiencies and pending labeling issues. The letter outlines the required actions for resubmission, including resolving manufacturing issues, revising prescribing information and carton/container labeling, resubmitting the proprietary name, and providing a comprehensive safety update.
This is a Complete Response Letter from the FDA to Spectrum Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) for SPI-2012. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality (manufacturing facility inspections), prescribing information, carton and container labeling, proprietary name resubmission, and the need for a comprehensive safety update.
This is a Complete Response letter from the FDA to Bioverativ USA, Inc. regarding their Biologics License Application (BLA) for sutimlimab. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies and recommendations that must be addressed for approval.
This letter from the FDA's Center for Drug Evaluation and Research addresses deficiencies in Biologics License Application (BLA) 761180, specifically requesting a resubmission of the proposed proprietary name and a comprehensive safety update.
The FDA issued two Complete Response letters for New Drug Application (NDA) 202049 for mannitol inhalation powder, indicating that the application cannot be approved in its current form. The first letter (Chiesi USA, Inc.) cited deficiencies in human factors (HF) validation studies for the Mannitol Tolerance Test (MTT), highlighting use errors and safety concerns regarding bronchospasm. The second letter (Pharmaxis Ltd.) identified an unfavorable benefit-risk balance for inhaled mannitol in cystic fibrosis patients, citing inadequate clinical efficacy data from trials and a high occurrence of hemoptysis. Both letters outline specific deficiencies, provide recommendations for resolution, and detail requirements for resubmission, including comprehensive safety updates and adherence to labeling guidelines.
This document is a Complete Response letter from the FDA to B. Braun Medical, Inc. for New Drug Application (NDA) 204957 for Acetaminophen Injection. The application cannot be approved in its current form due to unresolved facility inspection deficiencies, pending labeling review, outstanding regulatory issues (including Mallinckrodt letters and Paragraph IV certification), and concerns regarding leachables and an unknown compound. The letter details requirements for a comprehensive safety update and outlines the process for resubmission.
This document is a Complete Response letter from the FDA to Mylan Laboratories Limited regarding their New Drug Application (NDA) 206610 for Acetaminophen for Injection, 1 g/vial. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, regulatory requirements (patent certifications), prescribing information, and safety update requirements.
This document is a Complete Response letter from the FDA to Actavis LLC regarding their New Drug Application (NDA) for Pemetrexed Injection 25 mg/mL. The FDA has determined that the application cannot be approved in its current form and outlines specific deficiencies and recommendations across Chemistry, Manufacturing, and Controls (CMC), Prescribing Information, and Safety Update sections.
This is a Complete Response letter from the FDA to Evoke Pharma, Inc. regarding their New Drug Application (NDA) for Gimoti (metoclopramide nasal spray). The FDA has determined that the application cannot be approved in its present form due to deficiencies in clinical pharmacology and product/device quality.
The FDA issued a Complete Response letter for New Drug Application (NDA) 209511 for bupivacaine hydrochloride collagen-matrix implants, indicating that the application cannot be approved in its current form. The letter details several nonclinical, product quality, and safety deficiencies, along with issues regarding the proposed indication and labeling, and provides recommendations for addressing these issues.
This is a Complete Response letter from the FDA to Sedor Pharmaceuticals, LLC regarding their New Drug Application (NDA) 210864 for Sesquient (fosphenytoin sodium) injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality (specifically, foreign particles), regulatory issues (reliance on reference listed drugs and Paragraph IV certifications), and requirements for prescribing information, carton/container labeling, proprietary name resubmission, and a comprehensive safety update. The letter outlines specific actions and information required for a complete response and resubmission.
This document is an electronic record of an "OTHER ACTION LETTER" from the Center for Drug Evaluation and Research (CDER), associated with application number 210933Orig1s000, detailing its electronic signature.
The FDA issued a Complete Response Letter for NDA 211964 for viloxazine hydrochloride extended-release capsules, indicating that the application cannot be approved in its present form due to objectionable conditions at a manufacturing facility, issues with prescribing information, carton and container labeling, and the need to add a Medication Guide statement.
This is a Complete Response letter from the FDA to Hikma Pharmaceuticals USA Inc. regarding their New Drug Application (NDA) for naloxone nasal spray, 8 mg. The FDA has determined that the application cannot be approved in its present form due to various deficiencies identified in product quality, manufacturing, and device-related aspects.
This letter from the FDA's Center for Drug Evaluation and Research outlines deficiencies in New Drug Application (NDA) 212122 for Breztri Aerosphere and provides detailed instructions for its resubmission. The deficiencies primarily concern efficacy data, labeling, proprietary name resubmission, and a comprehensive safety update.
This is a Complete Response letter from the FDA to Par Sterile Products, LLC, informing them that their New Drug Application (NDA) for Micafungin for Injection cannot be approved in its current form. The letter outlines specific deficiencies across product quality, nonclinical studies, labeling, safety updates, and facility inspections that must be addressed before approval.
This is a Complete Response letter from the FDA to Ingenus Pharmaceuticals, LLC regarding their New Drug Application (NDA) for Cyclophosphamide Injection. The FDA has determined that the application cannot be approved in its current form due to deficiencies related to facility inspections, prescribing information, carton and container labeling, and the need for a safety update.
This is a Complete Response Letter from the FDA to Althera Life Sciences, LLC, for their New Drug Application (NDA) 213072 for rosuvastatin and ezetimibe tablet. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, facility inspections, and pediatric assessment requirements.
The FDA issued a Complete Response letter for NDA 214429 for Fexinidazole tablets, indicating that the application cannot be approved in its current form due to deficiencies primarily related to product labeling and the need for an updated safety profile.
This is a Complete Response Letter from the FDA to PharmaEssentia Corporation regarding Biologics License Application (BLA) 761166 for P1101, indicating that the application cannot be approved in its current form due to several deficiencies.
This letter from the FDA is a Complete Response to Ferring Pharmaceuticals, Inc.'s New Drug Application (NDA) for a progesterone vaginal ring, indicating that the application cannot be approved in its present form. The letter outlines several deficiencies related to device biocompatibility, clinical safety and efficacy, prescribing information, proprietary name resubmission, and safety update requirements, providing specific recommendations for addressing these issues.
The FDA issued a Complete Response Letter for Agile Therapeutics, Inc.'s New Drug Application (NDA 204017) for a levonorgestrel/ethinyl estradiol transdermal contraceptive delivery system. The application cannot be approved in its current form due to significant product quality issues related to the adhesion performance of the transdermal system, deficiencies in manufacturing facility observations, and clinical concerns regarding efficacy, high Pearl Index, and high subject discontinuation rates, which may be linked to the adhesion problems. The letter outlines specific deficiencies and provides recommendations for addressing them across product quality, facility inspections, clinical data, PREA requirements, prescribing information, proprietary name, and safety updates.
This is a Complete Response letter from the FDA to Dr. Reddy's Laboratories, SA, for their New Drug Application (NDA) 206966 for Xeglyze (abametapir) Lotion, 0.74%. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name resubmission, and the need for a comprehensive safety update.
This document is an 'Other Action Letter' from the FDA regarding New Drug Application (NDA) 208232 for Mycapssa. It details significant deficiencies found in the application, particularly concerning the efficacy data from study CH-ACM-01, where the estimate of efficacy could not distinguish Mycapssa's effect from other confounding factors. The letter also outlines specific requirements for labeling, carton and container labeling, proprietary name resubmission, and a comprehensive safety update, instructing the applicant on the necessary steps for resubmission or other actions within one year.
The FDA issued a Complete Response letter for NDA 208352 for Amphora vaginal gel, indicating that the application cannot be approved in its present form. The decision is based on deficiencies in clinical trial data, particularly regarding the generalizability of Russian data, insufficient cycles for safety and efficacy analysis, and concerns about study conduct. Additionally, there are deficiencies related to facility inspections, device description, biocompatibility testing, bench testing, and stability/shelf life of the applicators. The letter also provides comments on prescribing information and carton/container labeling requirements.
The FDA issued a Complete Response letter for New Drug Application (NDA) 209510 for Barhemsys (amisulpride) injection, indicating that the application cannot be approved in its current form. Deficiencies were identified in product quality/facility inspections, prescribing information, proprietary name, and safety update requirements. The letter outlines specific actions and data submissions required for potential approval, including resolving manufacturing issues, providing comprehensive safety data updates, and addressing labeling concerns.
The FDA issued a Complete Response letter for NDA 209529 for solifenacin succinate oral suspension, indicating that the application cannot be approved in its current form due to manufacturing facility deficiencies, inadequate control of raw material quality, and insufficient drug product specifications and stability programs regarding objectionable microorganisms. The letter outlines specific actions required for resubmission.
This document is a Complete Response letter from the FDA to Lannett Holdings, Inc. regarding their New Drug Application (NDA) 209575 for Cocaine Hydrochloride Topical Solution, 4% and 10%. The FDA has determined that the application cannot be approved in its present form due to several deficiencies in clinical, nonclinical, and regulatory aspects, and provides recommendations for addressing these issues.
This document is a Complete Response Letter from the FDA to Recro Pharma Inc. regarding their New Drug Application (NDA) for Meloxicam Injection. The FDA has determined that the application cannot be approved in its current form due to clinical deficiencies related to the drug's onset of action, duration of efficacy, and inadequate safety data. The letter also outlines deficiencies in carton and container labeling, and requests a comprehensive safety update upon resubmission. The applicant is advised on the process for resubmission or other actions.
The FDA issued a Complete Response letter for Mylan GmbH's New Drug Application (NDA 210605) for insulin glargine injection 100 units/mL, indicating that the application cannot be approved in its current form. Key deficiencies include unresolved objectionable conditions at the Biocon Sdn. Bhd. manufacturing facility, non-conformance of proposed Prescribing Information (PI) and Instructions for Use (IFU) with regulatory requirements, and the need for a comprehensive safety update. The letter provides detailed recommendations for addressing these issues and outlines the process for resubmission.
This is a Complete Response letter from the FDA to Trevena, Inc. regarding their New Drug Application (NDA) for Oliceridine injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies identified in clinical, nonclinical, product quality, and labeling aspects.
This document is a Complete Response letter from the FDA to Sunovion Pharmaceuticals Inc. regarding their New Drug Application (NDA) 210875 for Kynmobi (apomorphine) sublingual film. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to human factors (HF) validation study, clinical pharmacology and biopharmaceutics, and safety characterization of oropharyngeal adverse events. The letter outlines specific reasons for the non-approval and provides recommendations for addressing these issues, including conducting a new HF validation study, completing a specific clinical study, and providing a comprehensive discussion and re-examination of safety data.
The FDA issued a Complete Response letter for NDA 211039 for fluorescein sodium and benoxinate hydrochloride ophthalmic solution, indicating that the application cannot be approved in its present form due to manufacturing facility non-compliance with current good manufacturing practice (cGMP) regulations.
This is a Complete Response Letter from the FDA to Recordati Rare Diseases Inc. regarding their New Drug Application (NDA) for Cystadrops (cysteamine ophthalmic solution) 0.37%. The FDA has determined that the application cannot be approved in its present form due to manufacturing facility compliance issues, inadequate manufacturing methods and controls, unresolved data deficiencies, and pending labeling and safety update requirements.
This document is a Complete Response Letter from the FDA to Braintree Laboratories, Inc. regarding their New Drug Application (NDA) 213135 for SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. The FDA has determined that the application cannot be approved in its present form due to product quality/facility inspection deficiencies, and provides recommendations for addressing these issues, including requirements for labeling, proprietary name resubmission, and a comprehensive safety update.
This is a Complete Response Letter (CRL) from the FDA regarding Biologics License Application (BLA) 761115 for sacituzumab govitecan, indicating that the application cannot be approved in its present form due to various deficiencies related to product quality, manufacturing, labeling, facility inspections, and safety data.
The FDA issued a Complete Response letter for NDA 200655 for Fluorodopa F 18 Injection, indicating that the application cannot be approved in its current form due to significant deficiencies in clinical/statistical data, particularly regarding Study #17's design, conduct, and follow-up, which failed to provide sufficient confirmatory evidence of effectiveness. The letter also outlines requirements for labeling, safety updates, and the resubmission process.
This document contains multiple letters from the FDA to Fera Pharmaceuticals, LLC regarding New Drug Application (NDA) 202408 for Avaclyr (acyclovir ophthalmic ointment) 3%. It includes two 'Complete Response' letters detailing deficiencies preventing approval and required actions, and one 'Rescind Complete Response' letter indicating that a previous complete response was issued in error and the application is now under review.
This is a Complete Response letter from the FDA to Vero Biotech, LLC, for their New Drug Application (NDA) 202860 for GeNOsyl® Delivery System (Nitric Oxide). The FDA has determined that the application cannot be approved in its present form due to deficiencies identified during facility inspections, issues related to the device's design and testing (CDRH concerns), and inadequacies in the human factors validation study.
The FDA issued a Complete Response letter for Clarus Therapeutics, Inc.'s New Drug Application (NDA) for testosterone undecanoate (TU) (oral), indicating that the application cannot be approved in its present form due to several deficiencies related to safety, analytical methods, and nonclinical studies.
This is a Complete Response letter from the FDA to Dr. Reddy's Laboratories, Limited, for New Drug Application (NDA) 206927/Original 1 for bortezomib for injection 3.5 mg/vial. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies related to product quality, labeling, facility inspections, and safety updates, along with recommendations for addressing these issues.
The FDA issued a Complete Response Letter for New Drug Application (NDA) 208193 for Ozobax (baclofen) oral solution, indicating that the application cannot be approved in its current form. The letter outlines deficiencies related to product quality, including the need for additional stability studies and addressing gaps in the control strategy. It also details requirements for updating prescribing information and container labels to conform with regulatory standards, including using the SRPI checklist and submitting content in Structured Product Labeling (SPL) format. Furthermore, the applicant is required to submit a revised Initial Pediatric Study Plan (iPSP) and resubmit the proposed proprietary name. The letter provides recommendations for addressing these issues and specifies the process for resubmission or requesting a meeting.
The FDA issued a Complete Response Letter for NDA 209354, informing Dow Pharmaceutical Sciences, Inc. that their New Drug Application for halobetasol propionate and tazarotene lotion, 0.01%/0.045%, cannot be approved in its current form. The primary reason cited is insufficient nonclinical toxicology data, specifically a lack of an adequate bridge to listed drugs, and higher relative bioavailability of the proposed combination product. The letter outlines specific deficiencies and provides recommendations for resolution, including additional nonclinical studies and a comprehensive safety update.
The FDA issued a Complete Response letter for Antares Pharma, Inc.'s New Drug Application (NDA) 209863 for testosterone enanthate subcutaneous injection, indicating that the application cannot be approved in its current form due to identified deficiencies related to clinical safety, labeling, and other administrative aspects.
This document is a Complete Response letter from the FDA to Teva Pharmaceuticals USA, Inc. regarding their New Drug Application (NDA) 210063 for Fulvestrant Injection, 250 mg/5 mL. The FDA has determined that the application cannot be approved in its present form due to various deficiencies in nonclinical data, product quality, combination product (device) requirements, and labeling.
This document is a Complete Response letter from the FDA to AB Pharmaceuticals, LLC, regarding New Drug Application (NDA) 210649 for Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets. The FDA has determined that the application cannot be tentatively approved in its present form due to deficiencies related to facility inspections and prescribing information.
This is a Complete Response letter from the FDA to Valeant Pharmaceuticals Ireland regarding their New Drug Application (NDA) for tetracaine hydrochloride ophthalmic solution, 0.5%. The FDA has determined that the application cannot be approved in its present form due to non-compliance with current good manufacturing practice (cGMP) regulations at the manufacturing facility and issues with proposed labeling.
This is a Complete Response letter from the FDA to Daiichi Sankyo Inc. regarding New Drug Application (NDA) 210895 for Welchol (colesevelam) chewable bar. The FDA has determined that the application cannot be approved in its present form due to product quality deficiencies related to manufacturing, and reserves comment on proposed labeling. The letter outlines specific actions required for resubmission.
This document is a Complete Response letter from the FDA to Proximagen, LLC regarding their New Drug Application (NDA) 211321 for Nayzilam (midazolam) nasal spray. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, primarily related to Quality System requirements, prescribing information, labeling, and facility inspections.
The FDA issued a Complete Response Letter for Sarepta Therapeutics' New Drug Application (NDA) 211970 for Vyondys 53 (golodirsen) injection, indicating that the application cannot be approved in its present form due to concerns regarding clinical benefit and significant safety issues, specifically serious infections related to drug delivery and renal toxicity.
This is a Complete Response Letter from the FDA to Amgen Inc. regarding their Biologics License Application (BLA) for romosozumab. The FDA has determined that the application cannot be approved in its present form due to concerns about increased cardiovascular risk and requires additional data and analyses.
The FDA issued a Complete Response letter for Sandoz Inc.'s Biologics License Application (BLA) 761045 for LA-EP2006, a proposed biosimilar to US-licensed Neulasta. The application cannot be approved in its current form due to deficiencies in demonstrating pharmacokinetic (PK) similarity, establishing a scientific bridge between products, and various product quality issues including media fill validation, requalification strategy, microbial challenge data, container closure integrity, and simulated air transportation study data. The letter also requires a comprehensive safety update, updated labeling, and addresses pediatric presentation requirements.
This is a Complete Response letter from the FDA to Amgen Inc. regarding their Biologics License Application (BLA) for Kanjinti (ABP 980). The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including unresolved facility inspection issues, pending labeling revisions, and requirements for a comprehensive safety update and additional manufacturing/testing data.
This document is a Complete Response letter from the FDA to Samsung Bioepis Co., Ltd. regarding their Biologics License Application (BLA) 761066 for SB4. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality, prescribing information, proprietary name, and safety updates.
The FDA issued a Complete Response letter for Pfizer's Biologics License Application (BLA 761081) for Trazimera (PF-05280014), indicating that the application cannot be approved in its current form. The letter details numerous product quality deficiencies and provides recommendations, primarily concerning cell bank stability, drug product fill weight, shipping validation, specification controls for various attributes (ADCC, iso Asp102, high mannose, Polysorbate 20, extractable content), storage conditions, method validation, process validation, media fill data, hold time studies, and capping process parameters.
This document is a Complete Response letter from the FDA to Evolus, Inc. regarding their Biologics License Application (BLA) 761085 for botulinum toxin Type A injection. The FDA has determined that the application cannot be approved in its present form due to various product quality, prescribing information, proprietary name, and safety update deficiencies. The letter outlines specific issues and provides recommendations for addressing them to facilitate a successful resubmission.
This is a Complete Response letter from the FDA to NorthStar Medical Radioisotopes, LLC regarding their New Drug Application (NDA) 202158 for TechneGen Generator System for Preparation of Sodium Pertechnetate Tc99m Injection. The FDA has determined that the application cannot be approved in its present form due to multiple deficiencies identified in clinical aspects (labeling, user manuals, training, human factor testing), product quality microbiology (sterility assurance, microbiological control, process validation, cleaning protocols, sterilization confirmation, manufacturing information), deficiencies in a referenced Drug Master File (DMF), and inadequate manufacturing facility inspections.
This is a Complete Response letter from the FDA to Armstrong Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 205920 for Primatene Mist (epinephrine inhalation aerosol). The FDA has determined that the application cannot be approved in its present form, primarily due to deficiencies in the human factors (HF) study which failed to demonstrate safe and effective use of the product for proposed over-the-counter (OTC) use. The letter outlines specific reasons for non-approval and provides detailed recommendations for addressing these issues, including further HF studies, labeling revisions, and a safety update.
This document is a Complete Response letter from the FDA to Sun Pharma Advanced Research Company Limited regarding their New Drug Application (NDA) for Xelpros (latanoprost ophthalmic emulsion), 0.005%. The FDA has determined that the application cannot be approved in its present form due to unresolved deficiencies related to manufacturing facilities and requires a comprehensive safety update.
This document is an 'Other Action Letter' from the FDA regarding New Drug Application (NDA) 206976, outlining deficiencies that need to be addressed before the application can be approved. It details specific requirements related to biopharmaceutics, quality control, labeling, proprietary name, and safety updates.
This is a Complete Response Letter from the FDA to Scilex Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 207962 for ZTlido (lidocaine patch 1.8%). The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to regulatory, clinical, clinical pharmacology, and nonclinical aspects.
This is a Complete Response Letter from the FDA to Belcher Pharmaceuticals, LLC, for their New Drug Application (NDA) 207987 for Ablysinol (Dehydrated Alcohol Injection, USP). The FDA has determined that the application cannot be approved at the present time due to various deficiencies related to clinical data, product quality (CMC), prescribing information, proprietary name, and facility inspections. The letter outlines specific issues and provides suggestions for addressing them, including a mandatory postmarketing study.
This is a Complete Response letter from the FDA to Teva Pharmaceuticals USA regarding their New Drug Application (NDA) 208042 for buprenorphine and naloxone sublingual film. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspection, prescribing information, Medication Guide, Risk Evaluation and Mitigation Strategy (REMS), and safety update requirements.
The FDA issued a Complete Response letter for New Drug Application (NDA) 208276 for the Implantable System for Remodulin (treprostinil) solution for injection, indicating that the application cannot be approved in its current form. The primary reasons for non-approval include the device component not being approvable, insufficient human factors data for safe and effective use, and insufficient data regarding the risk of microbial contamination in the implantable pump system.
The FDA issued two Complete Response letters for New Drug Application (NDA) 208288 for SoluPrep™ to 3M Health Care. The letters detail reasons for non-approval, including nonclinical deficiencies related to impurity qualification and systemic toxicity assessment, requirements for a comprehensive safety update, and clinical deficiencies regarding replicative efficacy in pivotal studies and insufficient financial disclosure information for subinvestigators. The application cannot be approved in its present form, and specific actions are required for resubmission.
The FDA issued a Complete Response letter to Sun Pharmaceutical Industries Limited for their New Drug Application (NDA) for INFUGEM (gemcitabine injection), indicating that the application cannot be approved in its present form due to deficiencies identified during facility inspections and issues related to clinical data presentation and labeling.
The FDA issued a Complete Response letter for NDA 208564 for estradiol vaginal insert, indicating that the application cannot be approved in its current form due to deficiencies primarily related to clinical safety data, particularly long-term endometrial safety, and issues with labeling, safety updates, chemistry, manufacturing, controls, and carton/container labeling.
This document is a Complete Response letter from the FDA to Salamandra, LLC regarding New Drug Application (NDA) 208647 for rosuvastatin capsules. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name, and safety update requirements.
This document is a Complete Response letter from the FDA to Ocular Therapeutix, Inc. regarding their New Drug Application (NDA) 208742 for DEXTENZA (dexamethasone ophthalmic insert). The FDA has determined that the application cannot be approved in its current form due to deficiencies related to product quality/facilities inspection, prescribing information, proprietary name, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.
This document contains two Complete Response letters from the FDA to Hospira, Inc. regarding their New Drug Application (NDA) 209191 for Bortezomib for Injection. Both letters state that the application cannot be approved in its current form and outline deficiencies that need to be addressed for resubmission. The first letter (dated February 22, 2018) primarily focuses on product quality (elemental impurities), labeling, and safety update requirements. The second letter (dated November 3, 2017, though appearing later in the text) highlights deficiencies found during a manufacturing facility inspection, in addition to similar labeling and safety update requirements.
This document is a Complete Response letter from the FDA to Ironshore Pharmaceuticals & Development, Inc. regarding their New Drug Application (NDA) 209311 for Jornay PM (methylphenidate hydrochloride) Modified Release Capsules. The FDA has determined that the application cannot be approved in its present form due to clinical safety concerns, specifically a high rate of insomnia, and outlines deficiencies and recommendations for resubmission.
This document is a Complete Response Letter from the FDA to Coherus BioSciences, Inc. regarding their Biologics License Application (BLA) 761039 for CHS-1701. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to immunogenicity, product quality, prescribing information, proprietary name, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.
This document is a Complete Response letter from the FDA to CELLTRION, Inc. regarding their Biologics License Application (BLA) for CT-P6. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, product quality, and the need for an updated safety profile.
This is a Complete Response letter from the FDA to CELLTRION, Inc. regarding their Biologics License Application (BLA) 761088 for the proposed biosimilar product CT-P10. The FDA has determined that the application cannot be approved in its current form due to deficiencies identified in facility inspections, clinical data, product quality, and other regulatory aspects. The letter outlines specific issues and provides recommendations for addressing them prior to resubmission.
