AYTU - ANI FDA Application And Other News: The Good Bad And Ugly Of Biopharma
ANI Pharmaceuticals Submit Application for Relaunching Cortrophin Gel
ANI Pharmaceuticals Inc. (ANIP) announced that it has submitted a Prior Approval Supplement to the FDA. The supplement has been filed with the Endocrinology Division of the regulatory body. The application pertains to the re-commercialization of Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The drug was initially approved by the FDA in 1954 and had over 54 indications on its approved label. Some of the most prominent conditions treated by the gel were ulcerative colitis, systemic lupus erythematosus, and multiple sclerosis.
ANI Pharmaceuticals