ACCORD BIOPHARMA INC – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Accord BioPharma Inc. regarding their Biologics License Application (BLA 761147) for INTPS, indicating it cannot be approved in its current form. The primary issues stem from deficiencies identified during a pre-license facility inspection, requiring the company to resolve these and provide the facility's response to the FDA Form 483, with potential for re-inspection. Product quality, specifically microbiology, was also cited as an issue, although details were redacted. The agency reserved comments on proposed prescribing, carton, and container labeling until other deficiencies are addressed. While the proprietary name was conditionally acceptable, it requires resubmission after all other issues are resolved. A comprehensive safety update is mandated, requiring detailed nonclinical and clinical safety data, including retabulated adverse events, case reports for serious events, updated exposure information, and a summary of worldwide safety experience. Accord BioPharma Inc. must fully address all deficiencies and resubmit the application within one year under 21 CFR 601.3(b), or the application may be withdrawn. A meeting with the FDA can be requested to discuss the necessary steps for approval.