ANI Pharmaceuticals Receives FDA Approval and Imminent Launch of Rifabutin Capsules USP
22 December 2021 - - US-based biopharmaceutical company ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received US Food and Drug Administration approval for the Abbreviated New Drug Application for Rifabutin Capsules USP, 150 mg, the company said.

ANI's Rifabutin Capsules are the generic version of the reference listed drug Mycobutin. The current annual US market for Rifabutin Capsules USP, 150 mg is approximately USD 16.6m, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

ANI Pharmaceuticals is engaged in developing, manufacturing, and marketing branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.

Its team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities.