FDA CRL - Sun Pharmaceutical Industries Limited

The FDA issued a Complete Response Letter (CRL) for New Drug Application (NDA) 215644 to Sun Pharmaceutical Industries Limited, indicating that the application for nilotinib capsules cannot be approved in its present form. This decision stems from several deficiencies, including issues identified during a Current Good Manufacturing Practice (CGMP) and pre-approval inspection of the listed manufacturing facility. Main violations include inadequate proposed prescribing information, carton, and container labeling, with a specific requirement to add a bolded pharmacist statement regarding the Medication Guide per 21 CFR 208.24(d). The facility inspection revealed deficiencies that necessitate satisfactory responses from the site to the FDA, potentially requiring re-inspections to confirm compliance. Additionally, the company is required to provide a comprehensive safety update, incorporating new nonclinical and clinical study data, re-tabulated adverse event frequencies, detailed case reports for serious events, updated exposure information, and a summary of worldwide safety experience, as outlined in 21 CFR 314.50(d)(5)(vi)(b). Sun Pharmaceutical Industries Limited must resubmit the application within one year, fully addressing all deficiencies listed in the CRL, including the previously accepted proprietary name. The drug product cannot be legally marketed until written approval is obtained.