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FDA letter monthly archive

FDA Letters Issued in June 2025

Browse FDA approval and complete response letters issued in June 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 218607 (Jun 27, 2025)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218607. It outlines deficiencies in the application concerning prescribing information, carton and container labeling, proprietary name, and safety updates. The letter provides detailed instructions for addressing these deficiencies, particularly for the safety update, and sets a one-year deadline for resubmission or other actions.

IssuedJun 27, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761027 (Jun 26, 2025)

This letter from the FDA outlines deficiencies in Biologics License Application (BLA) 761027, requiring the applicant to revise labeling, resubmit the proprietary name, and provide a comprehensive safety update. It also specifies the timeline and format for resubmission.

IssuedJun 26, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 215644 (Jun 25, 2025)

This section outlines requirements for responding to deficiencies identified during inspections and for providing a comprehensive safety update for New Drug Application (NDA) 215644. It details specific content and formatting for the safety update, including new data integration, comparative tables, and narrative summaries for adverse events and trial discontinuations.

IssuedJun 25, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 210168 (Jun 20, 2025)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 210168. It reserves comment on proposed labeling until the application is otherwise adequate and outlines required actions for the applicant within one year, including resubmission or withdrawal, and emphasizes that the drug cannot be marketed until approved.

IssuedJun 20, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217382 (Jun 2, 2025)

The FDA has issued a deficiency letter for NDA 217382 concerning Nutrilipid 20%. Key issues include the lack of an adequate scientific bridge between Nutrilipid 20% and Intralipid 20% due to statistically significant physicochemical differences and insufficient data on comparable drug capture capability. The application also has deficiencies in human factors validation studies, indicating unsafe user interface for critical tasks. The FDA reserves comment on proposed labeling until other issues are resolved and requests comprehensive updates to safety data, benefit-risk assessments, and clarification on the proposed indication, especially for pediatric use and non-life-threatening Local Anesthetic Systemic Toxicity (LAST).

IssuedJun 2, 2025
US FDA• Nutrilipid 20%