Seikagaku Corporation – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Seikagaku Corporation for its Biologics License Application (BLA 761393) concerning an injection. The application cannot be approved in its current state due to several unaddressed issues. Key concerns include deficiencies identified during pre-license facility inspections, necessitating satisfactory responses from the manufacturing facility. Issues related to Product Quality Microbiology were also noted. Additionally, the FDA identified deficiencies in the proposed prescribing information and terminated the review of the proprietary name until all application deficiencies are resolved. A critical requirement for resubmission is a comprehensive safety update, as outlined in 21 CFR 314.50(d)(5)(vi)(b). This update must include new safety data, combined tabulations of adverse events, updated exposure information, a summary of worldwide experience, and translated foreign labeling. Seikagaku Corporation is required to address all identified deficiencies and resubmit the application within one year, with a clear indication that it is a complete response. The product cannot be legally marketed until the FDA grants written approval.