Gan & Lee Pharmaceuticals – FDA CRL

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Biologics License Application (BLA) 761356 submitted by Gan & Lee Pharmaceuticals for their proposed insulin aspart product. The application cannot be approved in its present form due to several unaddressed issues.

Key deficiencies include unresolved product quality concerns and issues identified during a pre-license facility inspection, for which deficiencies were communicated via an FDA Form 483. The company must provide the facility's response to the Form 483, and resolution may necessitate reinspection. Additionally, the FDA requires a comprehensive safety update incorporating new nonclinical and clinical data, detailed adverse event tabulations, reasons for study discontinuations, case reports for deaths or serious adverse events, and a summary of worldwide product experience.

Further actions include updating the proposed prescribing information to comply with format guidelines and submitting it in structured product labeling (SPL) format, resubmitting the conditionally acceptable proprietary name, and revising carton and container labeling. Under regulatory framework 21 CFR 601.3(b), Gan & Lee Pharmaceuticals must resubmit the application, fully addressing all deficiencies, or take other actions within one year. The product cannot be legally marketed until written approval from the FDA is received.