FDA CRL - ROXANE LABORATORIES INC

On May 3, 2013, the FDA issued a Complete Response Letter to Roxane Laboratories, Inc. regarding its New Drug Application for Cyclophosphamide Capsules (25 mg and 50 mg), submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The FDA determined the application could not be approved in its current form due to product quality concerns. While the letter does not provide specific inspection dates, it identifies that one of the three registration batches failed to meet required specifications for dissolution and impurity levels. To address these issues, Roxane Laboratories must take several actions. They are required to submit new data from three registration batches for each dosage strength that comply with all quality specifications. Furthermore, the company must provide a comprehensive safety update including data from all nonclinical and clinical trials, narrative summaries of serious adverse events, and a summary of worldwide safety experience. Revised product labeling in the Structured Product Labeling format is also required. Under 21 CFR 314.110, the company has one year to resubmit the application or request an extension. A full response addressing all deficiencies is necessary to restart the review cycle.