Sun Pharma Advanced Research Company Limited – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Sun Pharma Advanced Research Company Limited regarding its New Drug Application (NDA 204417) for Elepsia XR (levetiracetam) extended-release tablets. This decision follows the FDA's rescission of the NDA's prior approval on September 23, 2015, the same date as this CRL. The main obstacle to approval involves deficiencies identified during recent inspections of Sun Pharmaceutical Industries, Limited facilities linked to the application. Satisfactory resolution of these manufacturing-related issues is a prerequisite for approval, based on the Federal Food, Drug, and Cosmetic Act (FD&C Act) framework governing NDAs. Additionally, the FDA requires updated prescribing information. This includes submitting revised draft labeling incorporating previously proposed changes and providing the content of labeling in Structured Product Labeling (SPL) format, as required by 21 CFR 314.50(l)(1)(i). To facilitate review, a marked-up copy highlighting all changes against the March 2, 2015, agreed-upon labeling, along with a clean Word version, is also requested. Sun Pharma Advanced Research Company Limited must address these deficiencies and resubmit the application, or take other appropriate actions under 21 CFR 314.110, within one year.