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FDA letter monthly archive

FDA Letters Issued in July 2024

Browse FDA approval and complete response letters issued in July 2024. 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 217338 (Jul 26, 2024)

The FDA issued a Complete Response letter for NDA 217338 for naproxen sodium, dextromethorphan hydrobromide, guaifenesin extended-release (ER) tablet, indicating that the application cannot be approved in its current form due to insufficient evidence supporting the proposed 12-hour duration of action and dosing regimen.

IssuedJul 26, 2024
US FDA• naproxen sodium , dextromethorphan hydrobromide , guaifenesin extended-release (ER) tablet
CRLComplete Response Letter

Complete Response Letter NDA 505b1 216195 (Jul 25, 2024)

This document is a Complete Response Letter (CRL) from the FDA for New Drug Application (NDA) 216195, outlining deficiencies that prevent approval and detailing the requirements for a complete response resubmission, including specific instructions for a safety update and addressing facility issues.

IssuedJul 25, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217433 (Jul 15, 2024)

This FDA letter for NDA 217433 outlines deficiencies related to product quality, human factors, prescribing information, carton and container labeling, and safety updates. The primary concern is the user interface's failure to support safe and effective use, as demonstrated by a human factors validation study where participants failed to administer the intended dose. The letter requires the applicant to implement user interface revisions, provide data demonstrating effectiveness, and submit a safety update with detailed new safety data. It also reserves comment on labeling until the application is otherwise adequate and provides instructions for resubmission.

IssuedJul 15, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 215029 (Jul 11, 2024)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 215029. It outlines deficiencies in the application, reserves comment on proposed labeling, addresses the proprietary name, and provides detailed instructions for a safety update and the resubmission process. The letter also specifies the timeframe for resubmission and options for meetings.

IssuedJul 11, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761326 (Jul 10, 2024)

This document is a deficiency letter from the U.S. Food and Drug Administration (FDA) regarding Biologics License Applications (BLA) 761326/Original 1 and 761326/Original 2. It outlines deficiencies found during facility inspections, clinical data review (specifically for BLA 761326/Original 1 concerning glycemic control in type 1 diabetes), and provides instructions for addressing prescribing information, proprietary name, and safety updates. The letter also specifies actions required within one year for resubmission or other regulatory actions.

IssuedJul 10, 2024
US FDA• NNC0148-0287
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218345 (Jul 1, 2024)

This document is a letter from the U.S. Food and Drug Administration (FDA) regarding New Drug Application (NDA) 218345. It addresses product quality, regulatory aspects, prescribing information, carton and container labeling, and provides detailed instructions for a required safety update.

IssuedJul 1, 2024
US FDA• Unknown