FDA CRL - Dr. Reddy's Laboratories Limited

The FDA issued a Complete Response Letter (CRL) to Dr. Reddy's Laboratories, Limited, on December 17, 2014, regarding their New Drug Application (NDA 206927) for bortezomib for injection 3.5 mg/vial. This action, taken under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, indicates that the application cannot be approved in its present form.

The primary issues identified relate to product quality. The Drug Master File (DMF 23996) referenced in the application was found to be inadequate, with deficiencies communicated to the DMF holder on December 4, 2014. Additionally, the FDA denied Dr. Reddy's request for a waiver from conducting an in vivo bioequivalence study. This denial was due to unresolved concerns regarding the identity of the drug substance and the structures within the drug product and its reconstituted solution.

To move forward, Dr. Reddy's must ensure the DMF deficiencies are adequately addressed and provide documentation of these actions. They are also required to either resolve the drug substance and drug product identity issues to support a resubmitted bioequivalence waiver request or conduct a bioequivalence study. Furthermore, a comprehensive safety update, incorporating all new nonclinical and clinical data, and updated product labeling in Structured Product Labeling (SPL) format, must be submitted for the application to be reconsidered for approval.