FDA accepts ANI Pharma application for relaunch of Cortrophin Gel

The FDA has accepted for review an application from ANI Pharmaceuticals (ANIP -2.9%) seeking approval to re-commercialize Purified Cortrophin Gel (repository corticotropin injection USP) 80U/mL. The agency’s action date is July 23.

The product, originally approved in the U.S. in 1954 and last used in the 1980s, will compete with Mallinckrodt’s (MNK +8.5%) Acthar Gel (repository corticotropin injection) if approved.

The company acquired the New Drug Application (NDA) from Merck in January 2016.

https://seekingalpha.com/news/3560148-fda-accepts-ani-pharma-application-for-relaunch-of-cortrophin-gel