FDA CRL - Accord Healthcare Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Accord Healthcare Inc. for its New Drug Application (NDA 216987) concerning bendamustine hydrochloride injection. The agency determined that the application cannot be approved in its current state. The primary reason for the refusal stems from unresolved deficiencies identified during a surveillance inspection of the manufacturing facilities involved with the application. Satisfactory resolution of these manufacturing issues is a prerequisite for approval.

While reserving detailed comments on the proposed prescribing and carton/container labeling, the FDA indicated that these would need to be updated to comply with regulatory standards, including submission in structured product labeling (SPL) format. Furthermore, any future resubmission must include a comprehensive safety update, as mandated by 21 CFR 314.50(d)(5)(vi)(b), detailing significant changes in the safety profile, presenting new and combined safety data, and providing worldwide safety experience.

Accord Healthcare Inc. is required to address all identified deficiencies and resubmit the application within one year; failure to do so may result in the application being considered withdrawn. The company also has the option to request a meeting with the FDA to discuss the necessary steps for approval. The product cannot be legally marketed until written approval is granted by the FDA.