Lupin gets USFDA nod for generic version of Mycobutin Capsules

NEW DELHI: Pharmaceutical firm Lupin today said it has received final approval from US health regulator to market the generic version of Mycobutin capsules of Pharmacia and Upjohn Company that are used while treating advance HIV infection.

The approval from the US Food and Drug Administration is for Rifabutin Capsules USP, in strength of 150 mg, said Lupin in a statement.

"Lupin Pharmaceuticals Inc (LPI), the company's US subsidiary would commence marketing the product shortly," it said further.

The drug is used for prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Lupin's Rifabutin Capsules are generic equivalent of Pharmacia and Upjohn Company's Mycobutin capsules.

Headquartered in Baltimore, Maryland, Lupin is the 5th largest generics player in the US and third in Japan and South Africa).