FDA CRL - B. Braun Medical, Inc.

The FDA issued a Complete Response Letter (CRL) to B. Braun Medical, Inc. for its New Drug Application (NDA 204957) concerning Acetaminophen Injection. The agency identified several deficiencies preventing approval, primarily stemming from unresolved product-specific and Good Manufacturing Practice (GMP) compliance issues observed during a recent inspection of B. Braun Medical's manufacturing facility. Satisfactory resolution of these facility observations is a mandatory prerequisite for approval.The CRL also mandated extensive revisions to both carton and container labeling. These included formatting changes for clarity (e.g., using commas for numbers 1,000 or greater), relocating critical safety statements like "CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION" for increased prominence, and repositioning the NDC number, lot number, and expiration date in accordance with regulatory standards to prevent misinterpretation and enhance user safety.A comprehensive safety update is also required, encompassing detailed changes in the drug's safety profile, presentation of new and combined safety data from clinical studies, retabulation of reasons for trial discontinuations, and provision of case report forms and narrative summaries for deaths or serious adverse events. This update must also include updated worldwide safety experience and exposure information.Additional recommendations, not directly linked to approvability but expected to be addressed, involve tightening drug product specifications for impurities and either identifying unknown compounds in leachables studies, confirming their presence in other FDA-approved products, or conducting further toxicology studies to ensure adequate safety margins for specific compounds. B. Braun Medical, Inc. must address all listed deficiencies and resubmit the application within one year, as per 21 CFR 314.110.