FDA CRL - Dr. Reddy's Laboratories Limited

The FDA issued a Complete Response Letter (CRL) to Dr. Reddy’s Laboratories Limited for its New Drug Application (NDA 210852) concerning Cyclophosphamide Injection. The agency concluded that the application could not be approved in its present state due to several identified deficiencies. A key issue involved unsatisfactory findings from recent inspections of two manufacturing facilities, including Dr. Reddy’s Laboratories Limited (FEI 3006549835), requiring resolution before approval. Additional concerns centered on the proposed Prescribing Information and carton/container labeling, which did not adhere to FDA content and format regulations, specifically 21 CFR 201.56(a) and (d) and 201.57. Furthermore, the company must submit a comprehensive safety update, in accordance with 21 CFR 314.50(d)(5)(vi)(b), detailing any significant safety profile changes, incorporating new clinical data, and summarizing worldwide safety experience. Dr. Reddy’s must fully address all outstanding deficiencies within one year, which includes rectifying facility issues, revising all labeling as per FDA guidance, and providing the detailed safety update. The resubmission must be clearly identified as a “RESUBMISSION” and confirm it constitutes a complete response to every point raised in the CRL.