Azurity Pharmaceuticals, Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Azurity Pharmaceuticals, Inc. for its New Drug Application (NDA 219122) for sitagliptin oral solution, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The FDA determined the application is not approvable in its current form due to several deficiencies.

A primary issue stems from a facility inspection where deficiencies, likely documented in an FDA Form 483, were identified concerning current good manufacturing practice (CGMP). The facility must provide satisfactory responses to these issues, achieve compliance, and may require re-inspection, including a pre-approval inspection (PAI). Azurity is responsible for coordinating with the facility to resolve these matters. Other critical actions include submitting a comprehensive safety update, incorporating all new nonclinical and clinical study data, detailed adverse event tabulations, updated exposure information, and a summary of worldwide safety experience. The proposed proprietary name, Brynovin, which was conditionally acceptable, requires resubmission. Additionally, comments on Prescribing Information and Carton and Container Labeling are reserved until other application deficiencies are addressed. Azurity Pharmaceuticals must fully resolve all identified deficiencies and resubmit the application within one year.