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# ANI Pharma sNDA for Purified Cortrophin Gel
- URL: https://www.fdaweb.com/ani-pharma-snda-for-purified-cortrophin-gel/
- Published: 2021-11-02T12:00:00.000Z
- Updated: 2026-09-14T17:21:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150499

FDA has approved an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome. Cortrophin gel is an adrenocorticotropic hormone, also known as purified corticotropin, according to the company..

Cortrophin gel was first approved in 1954 and used for decades to treat certain chronic autoimmune disorders. ANI says it acquired the NDA from Merck in 2016 and spent the past five years working to bring the product back to market by “establishing and updating manufacturing processes and ensuring a sustainable, U.S.-based supply chain.”