FDA CRL - Sun Pharmaceutical Industries Limited

The FDA issued a Complete Response Letter for Sun Pharmaceutical Industries Limited's New Drug Application (NDA 208313) for INFUGEM (gemcitabine injection), 10 mg/mL, filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The agency cannot approve the application in its current state due to several unaddressed issues.

Key issues include deficiencies identified during recent inspections of Sun Pharmaceutical's manufacturing facility (FEI: 3002809586), which require satisfactory resolution. Additionally, the FDA requires revisions to the proposed prescribing information, including justification for dose banding instructions to ensure drug safety and efficacy, and specific corrections to carton and container labeling regarding the established name and storage conditions. The company must also resubmit the proposed proprietary name, INFUGEM.

A comprehensive safety update is a major requirement, demanding the incorporation of all new nonclinical and clinical study data, detailed analysis of adverse events and trial discontinuations, submission of case report forms for deaths or serious adverse events, and an updated summary of worldwide safety experience, including English translations of foreign labeling.

Sun Pharmaceutical Industries Limited must address all deficiencies and resubmit the application within one year, as per 21 CFR 314.110, or the application may be withdrawn. A meeting with the FDA can be requested to discuss these requirements. The drug cannot be marketed until formal written approval is received.