Assyro AI

FDA LETTER LIBRARY

Complete response & enforcement letters

One place to review FDA responses, identify remediation themes, and open the interactive co-pilot for every letter.

Showing 145-156 of 291 letters

ALApproval Letter

Approval Letter Other 214927 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• arimoclomol capsules
ALApproval Letter

Approval Letter Other 215064 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Filsuvez (birch triterpenes) gel
ALApproval Letter

Approval Letter Other 215151 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Voquezna
ALApproval Letter

Approval Letter Other 215040 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Legubeti (acetylcysteine) for oral solution
ALApproval Letter

Approval Letter Other 215179 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Pemetrexed Injection
ALApproval Letter

Approval Letter Other 215192 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• vadadustat tablets
ALApproval Letter

Approval Letter Other 215212 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Meropenem for Injection 2 g/vial
ALApproval Letter

Approval Letter Other 215320 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Combogesic (acetaminophen/ibuprofen) solution for injection
ALApproval Letter

Approval Letter Other 215721 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• zolpidem tartrate capsules
ALApproval Letter

Approval Letter Other 216490 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• palopegteriparatide injection
ALApproval Letter

Approval Letter Other 215344 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) for oral solution
ALApproval Letter

Approval Letter Other 217202 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• landiolol injection

Page 13 of 25

Previous
1…1112131415…25
Next