ANI gets FDA OK for generic Mycobutin
ANI has obtained the Food and Drug Administration’s clearance for rifabutin capsules, 150 mg.
The medication is the generic of Pfizer’s Mycobutin.
It is indicated for the prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection.
[Read more: FDA gives ANI green light for Cortrophin Gel]
Rifabutin capsules have a market value of approximately $16.6 million, according to IQVIA.
"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,” said Nikhil Lalwani, ANI president and CEO.