ACCORD BIOPHARMA INC – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Accord BioPharma Inc. concerning its Biologics License Application (BLA 761424) for INTP23.1, indicating that the application cannot be approved in its current form. Key issues include unresolved deficiencies from a pre-license facility inspection, documented in an FDA Form 483, for which satisfactory responses are required. Significant problems also involve product labeling; the Prescribing Information must be revised to conform with FDA regulations (e.g., 21 CFR 201.56 and 201.57) regarding content and format, including submission in Structured Product Labeling (SPL) format. Carton and container labeling also needs updating, specifically to include a mandatory Medication Guide statement as per 21 CFR 208.24(d). While a Risk Evaluation and Mitigation Strategy (REMS) is deemed necessary to manage the risk of severe hypocalcemia, further discussions will occur after the company's complete response. Accord BioPharma Inc. is additionally required to submit a comprehensive safety update, incorporating new nonclinical and clinical study data, detailed adverse event reporting, and global safety experience. Proprietary names, previously conditionally accepted, must be resubmitted once all identified deficiencies are resolved. The company must address these issues and resubmit the application or take other actions within one year, in accordance with 21 CFR 601.3(b).