FDA CRL - Wedgewood Pharmacy LLC

The FDA issued a Complete Response Letter to CMP Development LLC concerning its New Drug Application (NDA 214952) for LIQREV (sildenafil) oral suspension, 10 mg/ml, deeming it unapprovable in its current state. The primary issues identified relate to product quality and facility compliance. Deficiencies were communicated following a review of records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, and during recent inspections of multiple manufacturing and testing facilities. Satisfactory resolution of these issues is required. Additionally, a crucial pre-approval inspection of one manufacturing site could not be conducted due to COVID-19 related travel restrictions, preventing the FDA from verifying Current Good Manufacturing Practices compliance. To address these, CMP Development LLC must resolve all facility-related deficiencies, resubmit updated prescribing information, re-submit the proprietary name LIQREV, and provide a comprehensive safety update. This update requires new nonclinical and clinical data, updated adverse event analyses, revised exposure information, a summary of worldwide safety experience, and translated foreign labeling. The company must address all deficiencies and resubmit the application within one year.