FDA CRL - Astellas Pharma US Inc.

Astellas Pharma US, Inc. received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application (NDA 209529) for solifenacin succinate oral suspension, 1 mg/mL, filed under section 505(b) of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the application is not approvable in its current state due to significant deficiencies identified during a recent review and manufacturing facility inspection. The primary issues include objectionable conditions observed at a key manufacturing site. Furthermore, the quality of a critical raw material is insufficiently controlled, leading to drug product batches that fail to meet proposed specifications. The drug product’s specification and post-approval stability program also lack adequate test methods and acceptance criteria to ensure the product is free from objectionable microorganisms originating from the raw material. To resolve these, Astellas must submit comprehensive raw material characterization studies, investigations, and corrective actions. They need to establish and validate additional quality control tests for the raw material and provide data from three validation batches demonstrating product quality. Revisions to the drug product specification and stability program are required to incorporate microbial testing. Additionally, the company must update prescribing information, labeling, and provide a comprehensive safety update. Approval is contingent upon satisfactory resolution of all noted deficiencies.