FDA CRL - METACEL PHARMACEUTICALS LLC

Metacel Pharmaceuticals, LLC received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA 208193) for Ozobax (baclofen) oral solution 1 mg/mL, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the application cannot be approved in its current form due to several deficiencies. The primary concerns revolve around Product Quality, specifically an inadequate manufacturing and control strategy. The FDA noted insufficient controls to assure the identity, purity, strength, and quality of the commercial drug product at release and throughout its shelf life. This included gaps in the manufacturing process, drug product validation, release and stability specifications, and stability studies. Any modifications to the product, manufacturing process, analytical procedures, or container closure system will necessitate new stability studies. Additional issues included deficiencies in the proposed labeling, such as inappropriate content in the dosage form and strength section, a blurry drug substance structure, and missing information in the "how supplied" section regarding dosage form, strength, identification, and in-use storage. The company also needs to address Pediatric Research Equity Act (PREA) requirements by submitting an initial Pediatric Study Plan (PSP) or requesting a waiver or deferral. Metacel Pharmaceuticals must fully address all cited deficiencies, including providing updated Certificates of Analysis for drug substance batches and resubmitting the proposed proprietary name. The company has one year to resubmit the application, which must be clearly marked as a "RESUBMISSION," or pursue other regulatory actions. A meeting with the FDA can be requested to discuss the necessary steps for approval.