FDA CRL - Dr. Reddy’s Laboratories SA (Parexel International)

On October 16, 2025, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Dr. Reddy’s Laboratories SA regarding its Biologics License Application (BLA 761376) for the product candidate DRL_RI. The FDA determined that the application cannot be approved in its current form due to unresolved deficiencies identified during a pre-license facility inspection. While specific inspection dates were not disclosed in the correspondence, the facility must address all observations listed on the issued Form 483 before the application can proceed.

The regulatory framework for this decision is based on 21 CFR 601.3, which governs the licensing of biological products. Beyond the facility issues, the FDA identified concerns related to product quality and microbiology. Dr. Reddy’s is required to submit a comprehensive safety update that integrates data from all clinical and nonclinical studies, including detailed reports on any adverse events and changes in the product’s safety profile. Additionally, the applicant must provide revised draft carton and container labeling and resubmit the proposed proprietary name for a final evaluation during the next review cycle.

To continue the approval process, the company must submit a complete resubmission addressing all identified deficiencies within one year. A partial response will not be accepted for review, and the product remains unapproved for marketing in the United States until these requirements are met.