Gan & Lee Pharmaceuticals – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Gan & Lee Pharmaceuticals for their Biologics License Application (BLA 761357) for "Gan & Lee Insulin lispro." The application cannot be approved in its current form due to several outstanding deficiencies. Key issues include unresolved findings from a pre-license inspection of a manufacturing facility, where FDA conveyed deficiencies via a Form 483. The company must address these site-specific concerns, and a reinspection may be required. Product quality issues were also noted. The FDA reserved comments on proposed prescribing information, carton, and container labeling, indicating they are currently inadequate and require revision to comply with regulatory standards, including submission in Structured Product Labeling (SPL) format. The proprietary name was conditionally acceptable but needs re-submission upon resolution of all other deficiencies. Furthermore, a comprehensive safety update is mandated. This update must detail significant changes in the safety profile, present new nonclinical and clinical study data, re-tabulate adverse events, provide case reports for serious events, and include updated worldwide safety experience and foreign labeling translations. Gan & Lee Pharmaceuticals must resubmit the BLA within one year, fully addressing all identified deficiencies, or risk withdrawal of the application. A meeting with the FDA can be requested to discuss the necessary steps for approval. The product cannot be legally marketed until approved.