FDA CRL - Laurus Generics, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for New Drug Application (NDA) 217719 to Laurus Generics, Inc., acting as the U.S. Agent for Laurus Labs Limited, India. Dated March 10, 2025, the letter communicates that the application for Darunavir and Ritonavir Tablets cannot be tentatively approved in its present form. The FDA acknowledged a major amendment, which extended the review goal date, but ultimately determined the application's inadequacy.The FDA's decision is primarily based on unspecified deficiencies categorized under "PRODUCT QUALITY." While the letter reserves specific comments on proposed prescribing information and container labeling until other issues are resolved, it clearly indicates fundamental problems precluding approval. An additional recommendation regarding in-use stability was noted, but this was not cited as an approvability issue.Under the regulatory framework of 21 CFR 314.110, Laurus Generics, Inc. is required to resubmit the application or take other appropriate actions within one year to address all identified deficiencies. A resubmission must be clearly marked and fully resolve the issues. The company may also request a meeting with the FDA to discuss the necessary steps for approval. The drug product cannot be distributed until it receives written tentative approval from the FDA.