FDA CRL - Accord Healthcare Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Accord Healthcare Inc. regarding its New Drug Application (NDA 215749) for Bendamustine Hydrochloride injection. The FDA could not approve the application due to significant deficiencies identified during recent surveillance inspections of two manufacturing facilities listed in the application. While specific inspection dates were not provided, satisfactory resolution of these observations is a prerequisite for approval.

Additionally, the FDA deferred comments on the proposed prescribing information and carton/container labeling until other identified issues are adequately addressed. Under the regulatory framework of 21 CFR 314.50(d)(5)(vi)(b), Accord Healthcare is required to provide a comprehensive safety update. This update must detail any significant changes in the safety profile, include new and retabulated adverse event data, updated clinical trial exposure information, and a summary of worldwide safety experience.

Accord Healthcare must fully address all deficiencies and resubmit the application, clearly marked as a "RESUBMISSION," within one year as per 21 CFR 314.110. The company may also request a meeting with the FDA to discuss the necessary actions for achieving approval. The product cannot be legally marketed until written approval from the FDA is granted.