Lupin receives FDA approval for Generic Mycobutin Capsules

26 Feb 2014 Evaluate

Pharma Major Lupin has received final approval for its Rifabutin Capsules USP, 150 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Pharmacia & Upjohn Company's Mycobutin Capsules 150 mg. Lupin Pharmaceuticals Inc. (LPI), the company's US subsidiary would commence marketing the product shortly.

Lupin's Rifabutin Capsules, 150 mg are generic equivalent of Pharmacia & Upjohn Company's Mycobutin Capsules 150 mg. Lupin's Rifabutin Capsules USP, 150 mg is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.Mycobutin Capsules had annual U.S sales of $18.6 million in 2013 (IMS MAT Dec, 2013).

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally.

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