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FDA letter monthly archive

FDA Letters Issued in March 2025

Browse FDA approval and complete response letters issued in March 2025. Each result links to a structured letter page with source PDF access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter

Complete Response Letter NDA 505b1 218571 (Mar 27, 2025)

This FDA letter for NDA 218571 outlines deficiencies in the application, particularly concerning labeling and safety data, and provides instructions for resubmission and further actions required for approval.

IssuedMar 27, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761377 (Mar 26, 2025)

This FDA letter outlines deficiencies and requirements for the applicant of Biologics License Application (BLA) 761377 to achieve approval. It details specific instructions for submitting revised prescribing information, carton and container labeling, proprietary name information, and a comprehensive safety update. The letter also provides guidance on the resubmission process and timelines.

IssuedMar 26, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761308 (Mar 20, 2025)

This FDA letter addresses deficiencies in Biologics License Application (BLA) 761308, providing detailed instructions for revising labeling, updating safety information, and resubmitting the application. It outlines specific requirements for content, format, and timelines to achieve potential approval, emphasizing that the product cannot be marketed until written approval is received.

IssuedMar 20, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 216586 (Mar 20, 2025)

The FDA issued a Complete Response Letter (CRL) for NDA 216586 for rivoceranib tablets, indicating that the application cannot be approved in its present form due to outstanding issues, primarily concerning the co-dependent approval of SHR-1210 and labeling adequacy.

IssuedMar 20, 2025
US FDA• rivoceranib tablets
CRLComplete Response Letter

Complete Response Letter BLA 761424 (Mar 13, 2025)

This FDA letter, identified as BLA 761424, outlines deficiencies in a Biologics License Application and provides detailed instructions for resubmission. It specifies requirements for updating prescribing information (labeling) to conform with regulations and guidances, and mandates a comprehensive safety update incorporating new clinical data, worldwide experience, and foreign labeling translations.

IssuedMar 13, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761393 (Mar 11, 2025)

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761393. It outlines deficiencies related to product quality, prescribing information, proprietary name, and requires a comprehensive safety update upon resubmission. The letter also provides instructions for resubmission and potential next steps.

IssuedMar 11, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217719 (Mar 10, 2025)

This section outlines the required actions for an applicant following an FDA letter regarding NDA 217719, including deadlines for resubmission or other actions, specific formatting for resubmissions, and conditions for product distribution.

IssuedMar 10, 2025
US FDA• Unknown