FDA to Review ANI’s Request for Cortrophin Gel Use

FDA to Review ANI’s Request for Cortrophin Gel Use

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FDA to Review ANI’s Request for Cortrophin Gel Use

The U.S. Food and Drug Administration (FDA) has agreed to review ANI Pharmaceuticals’ supplemental new drug application for the approval of Cortrophin Gel to treat people with multiple sclerosis (MS) and other chronic inflammatory conditions, including rheumatoid arthritis. Purified Cortrophin Gel (repository corticotropin injection USP) is a purified adrenocorticotropic hormone (ACTH) that works by stimulating the adrenal cortex to produce cortisol, corticosterone, and aldosterone, among others. These steroids help to reduce inflammation and more rapidly…

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