FDA CRL - Ferring Pharmaceuticals Inc

Ferring Pharmaceuticals Inc. has received a Complete Response Letter from the FDA regarding its Biologics License Application (BLA 761253) for the product FE 999049. The FDA determined that the application cannot be approved in its current form due to several outstanding issues identified during the review process. A primary concern involves deficiencies found during a pre-license facility inspection, which resulted in the issuance of an FDA Form 483. Ferring must ensure the facility provides satisfactory responses to these deficiencies before the application can proceed. Additionally, the FDA requires a comprehensive safety update covering all clinical and nonclinical studies. This update must include detailed data on adverse events, comparative frequency tables, narratives for patient deaths or dropouts, and updated worldwide safety experience, including foreign labeling translations. The agency also noted that review of prescribing information and container labeling is deferred until other deficiencies are resolved, and the conditionally accepted proprietary name must be resubmitted. Under the regulatory framework of 21 CFR 601.3(b), Ferring has one year to provide a complete resubmission addressing all identified issues. Failure to respond within this timeframe may result in the application being withdrawn. The product remains unapproved for legal marketing until Ferring successfully addresses these requirements and receives written FDA approval.