FDA CRL - Salamandra, LLC

The FDA issued a Complete Response Letter (CRL) to Salamandra, LLC, regarding their New Drug Application (NDA 208647) for rosuvastatin capsules (5mg, 10mg, 20mg, 40mg), submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application cannot be approved in its current state due to several unaddressed issues. A key concern involves unresolved deficiencies identified during a recent inspection of Sun Pharmaceutical Industries Limited in Halol-Baroda, Gujarat, India. Satisfactory resolution of these facility issues is a prerequisite for approval. The FDA also requires a comprehensive safety update, which must include detailed changes in the safety profile, incorporation of new nonclinical and clinical study data, updated adverse event frequencies, case reports for serious adverse events or deaths, and a summary of worldwide safety experience.

Additionally, the agency reserved comments on the proposed prescribing information until other deficiencies are resolved, advising submission in structured product labeling (SPL) format. The proprietary name, Ezallor, was found acceptable but must be resubmitted with the responses to other issues. Salamandra, LLC must address all listed deficiencies by resubmitting the application or taking other specified actions within one year to avoid potential application withdrawal. The company may also request a meeting to discuss the required steps for approval.