AMNEAL EU LTD – FDA CRL

The FDA issued a Complete Response Letter (CRL) for New Drug Application (NDA) 218345 to Amneal EU, Ltd. (c/o Amneal Pharmaceuticals of New York, LLC.) on July 1, 2024. The agency determined that the application cannot be approved in its current form due to identified deficiencies across multiple areas. Key issues requiring resolution include concerns within the nonclinical and product quality sections of the application. While specific details were not provided, these areas require comprehensive remediation. The FDA also reserved comment on proposed prescribing information and carton/container labeling until other deficiencies are addressed, indicating future revisions will likely be necessary. A critical required action for resubmission involves a comprehensive safety update. Amneal must include detailed new safety data from all studies, present combined tabulations of new and original data, compare adverse event frequencies, and provide specific information on trial discontinuations, subject deaths, serious adverse events, updated exposure data, worldwide safety experience, and English translations of foreign labeling as per 21 CFR 314.50(d)(5)(vi)(b). Under 21 CFR 314.110, Amneal must resubmit a complete response addressing all deficiencies within one year, clearly marked as a "RESUBMISSION." The product cannot be legally marketed until written approval is obtained.