ANI Pharmaceuticals Gets FDA Nod For Cortrophin Gel 1-mL Vial

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) Monday said a 1-mL vial of Cortrophin Gel has been approved by the Food and Drug Administration (FDA), and is now commercially available.

Cortrophin Gel is already available in a 5-mL vial for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis.

Cortrophin Gel, also known as purified corticotropin, is an adrenocorticotropic hormone (ACTH).

Cortrophin Gel was first approved in the U.S. in the 1950s to treat various autoimmune diseases. ANI acquired the the rights over Cortrophin Gel from Merck in 2016, and reintroduced it to the market in January 2022 for the treatment of patients with acute gouty arthritis flares.