FDA CRL - Dr. Reddy'S Laboratories

The FDA issued a Complete Response Letter (CRL) to Dr. Reddy’s Laboratories, SA regarding their New Drug Application (NDA 206966) for Xeglyze (abametapir) Lotion, 0.74%. This application, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act, cannot be approved in its current form due to several outstanding issues. A key concern is the unresolved manufacturing facility deficiencies identified during a recent inspection of the Dr. Reddy’s Lab Ltd. CTO Unit VI facility. The FDA requires satisfactory resolution of these deficiencies before approval can be considered. Additionally, Dr. Reddy’s Laboratories must provide a comprehensive safety update, encompassing new clinical and nonclinical data, detailed analysis of adverse events, updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. While the proposed proprietary name, Xeglyze, was previously found acceptable, it needs to be resubmitted. The FDA also deferred comments on prescribing information, instructing the company to adhere to labeling requirements and submit updated content in Structured Product Labeling (SPL) format. To gain approval, Dr. Reddy’s Laboratories must address all identified deficiencies and resubmit the application within one year. The company has the option to request a meeting with the FDA to discuss the necessary steps for resolution.