Shilpa Medicare Limited – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Shilpa Medicare Limited regarding its New Drug Application (NDA) 212782 for bortezomib injection, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Following a review of the application, including an amendment submitted February 3, 2023, the FDA determined the application cannot be approved in its current form.

Key issues cited include product quality deficiencies, such as the need to incorporate a gross content test with acceptance criteria into drug product specifications, perform a risk assessment and confirmatory testing for a specific component, conduct a one-time leachable study on stability batches, and provide updated long-term stability data. The FDA also noted an inadequate response concerning the manufacturing process. Furthermore, unresolved deficiencies were identified during a surveillance inspection of the manufacturing facility, requiring satisfactory resolution. The company is also required to provide a comprehensive safety update, detailing any significant changes or findings in the safety profile, including tabulations of new and combined safety data as per 21 CFR 314.50(d)(5)(vi)(b).

To achieve approval, Shilpa Medicare Limited must fully address all identified deficiencies. The company has one year to resubmit the application or take other regulatory actions.