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FDA letter monthly archive

FDA Letters Issued in October 2024

Browse FDA approval and complete response letters issued in October 2024. Each result links to a structured letter page with source PDF access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter

Complete Response Letter BLA 761147 (Oct 29, 2024)

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761147. It addresses proposed labeling, proprietary name, and outlines detailed requirements for a safety update, including specific data presentation and analysis. It also provides instructions for resubmission and potential consequences of inaction.

IssuedOct 29, 2024
US FDA• Unknown (BLA 761147)
CRLComplete Response Letter

Complete Response Letter NDA 505b1 215644 (Oct 25, 2024)

This document outlines specific requirements for updating safety data in a New Drug Application (NDA), focusing on incorporating new clinical trial findings, adverse event reporting, and global safety information.

IssuedOct 25, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218600 (Oct 21, 2024)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218600. It outlines deficiencies and provides detailed instructions for resubmitting the application, focusing on labeling, proprietary name, and safety updates.

IssuedOct 21, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 219045 (Oct 21, 2024)

The FDA has reviewed a New Drug Application (NDA 219045) for a naloxone HCl, 4 mg, nasal spray. While the product's efficacy is considered comparable to Narcan, significant safety concerns exist due to its higher systemic exposure, which is greater than Narcan. This higher exposure poses an increased risk of precipitated opioid withdrawal, especially in opioid-dependent individuals and in a nonprescription setting without healthcare guidance. The submitted safety data is deemed inadequate, and communicating this risk effectively on a Drug Facts Label (DFL) is challenging. The FDA recommends either product reformulation to achieve lower systemic exposure or conducting further studies to establish the safety of the current higher-exposure formulation for nonprescription use, along with potential labeling modifications. A comprehensive safety update is also required.

IssuedOct 21, 2024
US FDA• naloxone HCl, 4 mg, nasal spray
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218923 (Oct 10, 2024)

This FDA letter communicates deficiencies in NDA 218923, deferring clinical inspections and reserving comments on labeling and proprietary name until the application is otherwise adequate. It outlines specific requirements for a safety update, including detailed data presentation and analysis, and provides instructions for resubmission within one year, emphasizing that all deficiencies must be addressed.

IssuedOct 10, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217724 (Oct 8, 2024)

This letter from the FDA communicates deficiencies found in New Drug Application (NDA) 217724 and outlines requirements for a complete response. Key areas of concern include manufacturing compliance (CGMP), prescribing information (labeling) content and format, proprietary name review, safety updates, and specific clinical data requests related to pediatric dosing, safety, and efficacy, particularly for infants with low body weight or prematurity. The applicant is required to address these deficiencies within one year, with specific instructions for resubmission.

IssuedOct 8, 2024
US FDA• Unknown