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 97-108 of 291 letters

ALApproval Letter

Approval Letter Other 018680 (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Paragard (intrauterine copper contraceptive)
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Gepirone Hydrochloride Extended Release 20mg, 40mg, 60mg, and 80mg tablets
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Lutrate®Depot (leuprolide acetate for injection)
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• DSUVIA (sufentanil sublingual tablet)
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Romidepsin Injection solution, 10 mg/2 mL (5 mg/mL)
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Elepsia XR (levetiracetam) extended-release tablets, 1000 mg and 1500 mg
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Wakix (pitolisant) 4.45 mg and 17.8 mg tablets
ALApproval Letter

Approval Letter Other 212097 (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Gvoke
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Unknown
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Jylamvo (methotrexate) oral solution
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• tivozanib hydrochloride capsules, 1.0 mg or 1.5 mg
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• VOCABRIA (cabotegravir) 30 mg tablets

Page 9 of 25

Previous
1…7891011…25
Next