Lupin receives FDA approval for generic mycobutin caps

Lupin has received final approval for its rifabutin capsules USP, 150 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Pharmacia and 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 and 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 US sales of $18.6 million (IMS MAT Dec, 2013).

EP News BureauMumbai

Comments (0)
Add Comment