U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin

ANI Pharmaceuticals announced that they have received U.S. Food and Drug Administration (FDA), approval for the Abbreviated New Drug Application for Rifabutin Capsules USP, 150 mg.

ANI’s Rifabutin capsules are the generic version of the reference listed drug Mycobutin. The current annual U.S. market for Rifabutin capsules USP, 150 mg is approximately US $ 16.6 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"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,” stated Nikhil Lalwani, President and CEO.