Lupin gets USFDA tentative nod for anti bacterial tablets
New Delhi : Drug firm Lupin has received tentative approval from the US health regulator to market its generic anti-bacterial moxifloxacin hydrochloride tablets in the American market.
The company's US subsidiary, Gavis Pharmaceuticals, has received tentative approval for its moxifloxacin hydrochloride tablets, 400 mg, from the United States Food and Drug Administration (USFDA), Lupin said in a filing to BSE.
The approval is to market the company's product, a generic version of Bayer Healthcare Pharmaceuticals' Avelox tablets in the same strength, it added.
Avelox had US sales of USD 30.1 million as per IMS MAT June 2016, Lupin said.
The stock of Lupin closed at Rs 1,535.50 on BSE, up 1.28 per cent from its previous close.