ANIP - ANI Pharmaceuticals announces FDA approval of Mycobutin generic

ANI Pharmaceuticals (NASDAQ:ANIP) is trading ~3.7% higher in the pre-market on below-average volume after announcing the FDA approval of its Abbreviated New Drug Application for Rifabutin Capsules USP, 150 mg. ANI’s newly approved Rifabutin capsules are a generic version of the Mycobutin, an oral antibiotic used to treat mycobacterium avium complex (MAC) in people infected with HIV. According to IQVIA/IMS Health, the current U.S. market for Rifabutin Capsules USP, 150 mg is projected at ~$16.6M. "We are pleased to announce the approval and imminent launch of Rifabutin Capsules,” remarked ANI CEO Nikhil Lalwani, adding that the authorization and commercialization of a second Rifabutin generic demonstrate the company’s R&D strength. Read why ANI (ANIP) shares surged following the company’s recent financials for Q3 2021.

For further details see:

ANI Pharmaceuticals announces FDA approval of Mycobutin generic