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FDA letter monthly archive

FDA Letters Issued in April 2025

Browse FDA approval and complete response letters issued in April 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 215818 (Apr 25, 2025)

This FDA letter, dated April 25, 2025, addresses New Drug Application (NDA) 215818, outlining specific requirements and recommendations related to product quality, prescribing information, carton and container labeling, and other general submission procedures. It emphasizes the need for the applicant to address deficiencies, update various data points, and adhere to specific formatting and submission guidelines before the application can be approved and the product legally marketed.

IssuedApr 25, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218353 (Apr 25, 2025)

This FDA letter communicates deficiencies in New Drug Application (NDA) 218353 for floretyrosine F 18, requiring the applicant to address issues related to efficacy evidence, dose optimization, prescribing information, carton and container labeling, and a comprehensive safety update. It outlines specific requirements for the safety update data presentation and sets a one-year deadline for resubmission or other actions.

IssuedApr 25, 2025
US FDA• floretyrosine F 18
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218592 (Apr 25, 2025)

This document is a Complete Response Letter (CRL) from the FDA to an applicant for New Drug Application (NDA) 218592, outlining deficiencies that prevent approval and detailing the necessary actions for resubmission.

IssuedApr 25, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 216442 (Apr 2, 2025)

The FDA has identified deficiencies in NDA 216442, primarily concerning the robustness of Study 030's primary efficacy endpoint analysis and the statistical methodology used. The agency requires the applicant to conduct at least one additional adequate and well-controlled study to demonstrate positive treatment effects for ocular symptoms of dry eye, without making unapproved protocol or statistical analysis plan changes. Further comments on prescribing information, carton/container labeling, and proprietary name are reserved until the application is otherwise adequate. A safety update is also required upon resubmission, and the applicant must take action within one year to resubmit or risk withdrawal of the application.

IssuedApr 2, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218345 (Apr 2, 2025)

This FDA letter provides feedback on NDA 218345, acknowledging revised labeling and carton/container labeling submissions, but reserving further comment until the application is otherwise adequate. It outlines detailed requirements for a safety update, including specific data presentation and analysis, and provides instructions for resubmission or other actions within one year.

IssuedApr 2, 2025
US FDA• Unknown