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ANI Pharma's Generic Version Of Mycobutin Gets FDA Approval

ANI Pharmaceuticals Inc. (ANIP) said on Tuesday that it has received FDA approval for a generic version of Pfizer's Mycobutin.

Mycobutin contains 150 mg of the Rifamycin antimycobacterial agent Rifabutin, USP, per capsule and is used to prevent mycobacterium avium complex (MAC) in people with HIV infection and to treat tuberculosis in people with HIV.

According to IQVIA/IMS Health, a healthcare data and analytics provider, the current annual U.S. market for Rifabutin Capsules USP, 150 mg is approximately $16.6 million.

Commenting on the approval Nikhil Lalwani, CEO of ANI Pharma said, "We are pleased to announce the approval and imminent launch of Rifabutin Capsules. The approval and commercialization of a second generic Rifabutin highlights further the strength of our R&D engine and our ability to rapidly bring limited market competition generic products to our patients in need and to our customers."

The first generic version of Mycobutin was approved by FDA in 2014 and that was developed by Lupin Ltd.

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