FDA CRL - Sun Pharma Advanced Research Company Limited

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Sun Pharma Advanced Research Company Limited for its New Drug Application (NDA) 206185, Xelpros (latanoprost ophthalmic emulsion), 0.005%. The FDA determined the application cannot be approved in its current form, referencing section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

The primary issue identified was unresolved deficiencies at the Sun Pharmaceutical Industries, Ltd. manufacturing facility, following a recent inspection. Satisfactory resolution of these product quality and facility-related concerns is mandatory for approval.

Additionally, the FDA requires a comprehensive safety update, as outlined in 21 CFR 314.50(d)(5)(vi)(b). This update must detail any significant changes in the safety profile, present new clinical and non-clinical safety data combined with original NDA data, include retabulations of adverse events and trial discontinuations, provide case report forms for deaths or serious adverse events, update exposure information, and summarize worldwide safety experience with English translations of foreign labeling. While the proposed proprietary name, Xelpros, was found acceptable, it needs to be resubmitted upon addressing other deficiencies. Comments on proposed labels and labeling are reserved until the application is otherwise adequate.

Sun Pharma is required to resubmit the application or take other actions within one year, fully addressing all deficiencies for a new review cycle. A meeting with the FDA can be requested to discuss the necessary steps.