ANIP - FDA grants expanded approval for ANI Pharmaceuticals' Cortrophin Gel

The U.S. FDA has approved ANI Pharmaceuticals' (NASDAQ:ANIP) sNDA for Purified Cortrophin Gel for the treatment of certain chronic autoimmune disorders. The approval allows for the use of Cortrophin in conditions, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome. The company anticipates a full-scale commercial launch by early in the first quarter of 2022. Cortrophin Gel was first approved in 1954 and used for decades to treat certain chronic autoimmune disorders. Shares down more than 6% premarket.

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FDA grants expanded approval for ANI Pharmaceuticals' Cortrophin Gel