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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 121-132 of 291 letters

ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• lenacapavir injection
ALApproval Letter

Approval Letter Other (Nov 13, 2025)

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.

IssuedNov 13, 2025
US FDA• Rezvoglar (insulin glargine-aglr) injection, 3 mL (100 Units/mL)
ALApproval Letter

Approval Letter Other 214697 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• Neffy (ARS-1, epinephrine nasal spray), 2 mg/0.1 mL
ALApproval Letter

Approval Letter Other 214759 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• Grafapex (treosulfan) for injection, for intravenous use
ALApproval Letter

Approval Letter Other 216962 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• Vyalev (foscarbidopa and foslevodopa) injection for subcutaneous use
ALApproval Letter

Approval Letter Other 218772 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• Arbli
ALApproval Letter

Approval Letter Other 761126 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• TX01
ALApproval Letter

Approval Letter Other 761258 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• AK105 (penpulimab-kcqx)
ALApproval Letter

Approval Letter Other 761297 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• cosibelimab (CK-301)
ALApproval Letter

Approval Letter Other 761315 (Jan 1, 2025)

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.

IssuedJan 1, 2025
US FDA• NNC0172-2021 injection
ALApproval Letter

Approval Letter Other 201848 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• Melblez Kit, [melphalan for injection, 50 mg per vial, and Delcath hepatic delivery system]
ALApproval Letter

Approval Letter Other 209471 (Jan 1, 2024)

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.

IssuedJan 1, 2024
US FDA• COMBOGESIC (ibuprofen 97.5 mg/acetaminophen 325 mg) Film-Coated Tablets

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