FDA CRL - Amneal Pharmaceuticals of New York, LLC

The FDA issued a Complete Response Letter (CRL) to Amneal EU, Limited, for its New Drug Application (NDA 218345) concerning phenylephrine hydrochloride in sodium chloride injection, indicating the application cannot be approved in its current form. A significant issue arose from a Current Good Manufacturing Practice (CGMP) inspection of a manufacturing facility, where deficiencies were identified. The company must ensure the facility adequately responds to these findings, which may require re-inspection and a preapproval inspection (PAI) to demonstrate full compliance with manufacturing standards.The regulatory framework for these actions includes adherence to CGMP and specific requirements under 21 CFR 314.50(d)(5)(vi)(b) for safety updates. The FDA also requires a comprehensive safety update as part of any resubmission. This update must detail all new safety data from clinical studies, including retabulations of adverse events, case reports for serious events or deaths, updated exposure information, and a worldwide safety profile. Comments on proposed prescribing information and carton/container labeling are deferred until all other deficiencies are resolved. Amneal must fully address all outstanding issues within one year and clearly label any resubmission as a complete response. A meeting with the FDA can be requested to discuss the path forward for approval.