Accord Healthcare Inc. – FDA CRL

Accord Healthcare Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA 218470) for Epinephrine injection. The FDA determined the application could not be approved in its current form due to several outstanding issues. A primary concern stemmed from facility inspections, where deficiencies were identified at a manufacturing site listed in the application, requiring satisfactory resolution. Additionally, the FDA noted product quality concerns. The agency also outlined extensive requirements for a comprehensive safety update, mandated under 21 CFR 314.50(d)(5)(vi)(b). This update must include data from all nonclinical and clinical studies, detailing any significant changes in the safety profile, presenting new safety data combined with original application data, comparing adverse event frequencies, providing case reports for deaths or serious adverse events, and submitting updated exposure information and worldwide safety experience, including foreign labeling translations. Comments on proposed prescribing, carton, and container labeling are reserved until these core issues are resolved. Accord Healthcare is required to resubmit the application, addressing all deficiencies, or take other actions within one year, as per 21 CFR 314.110. A meeting with the FDA can be requested to discuss the necessary steps for approval. The Epinephrine injection cannot be marketed until formal approval is granted.