Shilpa Medicare Limited – FDA CRL

The FDA has issued a Complete Response Letter (CRL) to Shilpa Medicare Limited for its New Drug Application (NDA 215179) for Pemetrexed Injection, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application cannot be approved in its current form due to significant unaddressed deficiencies.

Key issues include an outstanding information request from May 30, 2021, regarding the deliverable volume (dose) data for the drug product. Furthermore, a recent inspection of the manufacturing facility identified deficiencies that require satisfactory resolution. The FDA has reserved comments on the proposed prescribing information and carton/container labeling until these primary product quality and facility issues are adequately addressed.

To achieve approval, Shilpa Medicare Limited must provide satisfactory resolutions for both the product quality data deficiency and the manufacturing facility observations. A comprehensive safety update, detailing any significant changes in the safety profile, integrating new clinical data, comparing adverse event frequencies, and including updated patient exposure and global safety experience, is also mandated upon resubmission. The company has one year to submit a complete response, clearly marked as a "RESUBMISSION," or pursue other available regulatory actions. A meeting with the FDA can be requested to discuss the necessary steps for approval.