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3 Feb 2015

Lupin gets USFDA approval for diarrhoea drug

Mumbai-based Lupin Limited has received final approval for its vancomycin hydrochloride capsules, 125 mg and 250 mg from the US Food and Drugs Administration (USFDA) to market a generic version of ANI Pharmaceuticals Inc’s Vancocin capsules. The company said that Lupin Pharmaceuticals Inc, Lupin’s US subsidiary, would commence marketing the product shortly.

Vancomycin is an antibiotic useful for the treatment of a number of bacterial infections. Lupin’s vancomycin capsules are the AB rated generic equivalent of ANI Pharmaceuticals Inc’s Vancocin capsules and are indicated for the treatment of C. difficile-associated diarrhoea and also for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains).

According to IMS MAT September, 2014, Vancocin capsules had annual sales of $ 164.2 million in the US.

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