FDA CRL - ACCORD BIOPHARMA INC

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Accord BioPharma Inc. regarding its Biologics License Application (BLA 761027) for INTP1. The FDA determined that the application cannot be approved in its current form due to several outstanding issues. A primary concern stems from unresolved deficiencies identified during recent inspections of the drug substance and drug product manufacturing facilities, as outlined in FDA Form 483. The company must provide satisfactory responses to these findings for the application to be reconsidered, potentially necessitating a re-inspection.

Furthermore, the FDA has reserved comments on the proposed prescribing information, carton, and container labeling until all other application deficiencies are adequately addressed. The proposed proprietary name was conditionally acceptable but requires resubmission once all issues are resolved.

A significant requirement involves a comprehensive safety update. Accord BioPharma must detail any changes in the safety profile, incorporate new clinical safety data, retabulate adverse events and study discontinuations, and provide case report forms for deaths or serious adverse events. This update also mandates inclusion of updated exposure information, a summary of worldwide safety experience, and English translations of any current foreign labeling.

Under 21 CFR 601.3(b), Accord BioPharma is required to resubmit the application, fully addressing all identified deficiencies, or take other actions within one year to avoid potential withdrawal under 21 CFR 601.3(c). The company may request a meeting to discuss the necessary steps before the product can be legally marketed.