Sun Pharmaceutical Industries Limited – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Sun Pharmaceutical Industries Limited for its New Drug Application (NDA 215644) concerning nilotinib capsules. The application cannot be approved in its current form due to several unresolved issues.

Key deficiencies include product quality and labeling concerns. The proposed prescribing information, carton and container labeling, and proprietary name require updates, with the FDA reserving full comment until other issues are resolved. Specifically, the Medication Guide must include a prominent statement for pharmacists regarding patient receipt, as mandated by 21 CFR 208.24(d).

A significant issue involves facility inspections. Following Current Good Manufacturing Practice (CGMP) and preapproval inspections, deficiencies were identified at a manufacturing site. The facility must provide satisfactory responses to the FDA Form 483 findings and demonstrate compliance with CGMP requirements. Re-inspections may be necessary before approval.

Additionally, Sun Pharmaceutical must submit a comprehensive safety update, as outlined in 21 CFR 314.50(d)(5)(vi)(b). This update needs to detail any significant changes in the safety profile, integrate new clinical data with original findings, and provide updated exposure information and worldwide safety experience.

The company must fully address all listed deficiencies and resubmit the application, clearly marked as a "RESUBMISSION," within one year. Failure to respond may lead to the application's withdrawal. The drug cannot be legally marketed until the NDA receives approval.