FDA CRL - Azurity Pharmaceuticals, Inc.

The FDA issued a Complete Response Letter (CRL) to Azurity Pharmaceuticals, Inc. for its New Drug Application (NDA 214273) concerning Zonisade (zonisamide) oral suspension. Submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, the application cannot be approved in its present form due to several critical issues. Key concerns include manufacturing facility deficiencies. During a recent inspection, one facility received conveyed deficiencies requiring satisfactory resolution. Additionally, issues were identified with LM MANUFACTURING LIMITED through a record review, necessitating an on-site inspection for Current Good Manufacturing Practice (CGMP) compliance, which could not be conducted during the review cycle due to travel restrictions. Beyond manufacturing, the FDA requires revisions to carton and container labeling, including a specific Medication Guide statement per 21 CFR 208.24(d). A comprehensive safety update, detailed under 21 CFR 314.50(d)(5)(vi)(b), is also mandated, requiring detailed safety profile changes, combined data, and narrative summaries for adverse events. Azurity Pharmaceuticals must address all deficiencies and resubmit the application within one year. Approval is contingent on resolving these issues and successfully completing all required facility inspections.