ACCORD BIOPHARMA INC – FDA CRL

Accord BioPharma Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA 761147) for INTPS. The FDA determined that the application cannot be approved in its current form due to several outstanding issues. A primary concern stems from multiple pre-license inspections of the manufacturing facility. The FDA found that responses from the facility provided insufficient evidence to confirm resolution of previously identified deficiencies. Accord BioPharma must provide satisfactory documentation addressing all issues noted on the most recent FDA Form 483, including re-inspection if deemed necessary. Additionally, the FDA requires a comprehensive safety update. This update must detail any significant changes in the safety profile, incorporate new clinical study data on adverse events and discontinuations, provide updated exposure information, and summarize worldwide safety experience, including foreign labeling. Comments on prescribing information, carton and container labeling, and the proprietary name are reserved pending resolution of these primary deficiencies, with the proprietary name requiring resubmission. Under 21 CFR 601.3(b), Accord BioPharma must fully address all identified deficiencies and resubmit the application within one year. Failure to do so may lead to the application's withdrawal. The product cannot be legally marketed until written approval is received. The company is encouraged to request a meeting to discuss the necessary steps for approval.