Drug major Lupin has received approval from the U.S. health regulator to sell a generic version of Vancocin capsules, used in treating diarrhoea, in the American market.
The company has received final approval for its Vancomycin Hydrochloride Capsules in strengths of 125 mg and 250 mg from the US Food and Drugs Administration (FDA) to market a generic version of ANI Pharmaceuticals, Inc’s Vancocin, Lupin Ltd said in a statement.
“Lupin Pharmaceuticals Inc (LPI), the company’s U.S. subsidiary would commence marketing the product shortly,” it added.
Vancomycin capsules are indicated for the treatment of C difficile-associated diarrhoea and also for the treatment of enterocolitis caused by Staphylococcus aureus.
As per the IMS MAT September, 2014 sales data, Vancocin capsules had annual U.S. sales of USD 164.2 million.
“This is Lupin’s fifth abbreviated new drug application (ANDA) approval in the last two months. These approvals and the subsequent launches represent a collective market size of over USD 5 billion for Lupin,” the company said.
Lupin shares were trading at Rs 1,575.05 apiece on the BSE, down 0.59 per cent from its previous close.