FDA Approves GLOPERBA Oral Colchicine Solution (NDA 210942)

FDA has approved GLOPERBA, a prescription oral solution of colchicine, manufactured by Scilex Pharmaceuticals Inc. The product is identified by the brand name GLOPERBA, generic name colchicine, and NDC 69557-222-01. The original NDA (210942) was approved in 2019 as a new dosage form. Subsequent submissions included a CMC supplement in 2021 and an efficacy supplement in 2024, both of which were approved by the agency. The solution contains colchicine at a strength of 0.6 mg per 5 mL and is intended for oral administration. FDA submission documents include labeling, letters, and medication guides, with the most recent label dated September 2, 2024.