Categories: US FDA Approval

Lupin gets USFDA nod for generic version of Mycobutin capsules

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

New Delhi February 28, 2014:- Pharmaceutical firm Lupin Ltd. on Wednesday said it has received final approval from the US health regulator to market the generic version of Mycobutin capsules of Pharmacia and Upjohn Co. that are used while treating advance HIV infection.
The approval from the US Food and Drug Administration (FDA) is forRifabutin 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 Co.’s Mycobutin capsules. Headquartered in Baltimore, Maryland, Lupin is the 5th largest generics player in the US and third in Japan and South Africa. PTI 

The Pharma Times News Bureau

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The Pharma Times News Bureau
11 years ago

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