WASHINGTON (dpa-AFX) - ANI Pharmaceuticals, Inc. (ANIP, BPAX) announced FDA has approved its supplemental New Drug Application (sNDA) for Purified Cortrophin Gel for the treatment of certain chronic autoimmune disorders including Multiple Sclerosis, Rheumatoid Arthritis and Nephrotic Syndrome. The company anticipates a full-scale commercial launch by early in the first quarter of 2022.
ANI Pharmaceuticals acquired the NDA for Cortrophin Gel from Merck & Co. in 2016. The company submitted an sNDA in June 2021 to bring Cortrophin Gel back to market for patients.
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