Drug firm Lupin today said US-based subsidiary Gavis Pharmaceuticals has received tentative approval from the USFDA for Azithromycin for oral suspension, an anti-bacterial drug, in the American market.
Gavis has received tentative approval for its Azithromycin for oral suspension USP from the United States Food and Drug Administration (FDA), Lupin said in a BSE filing.
The company’s product is a generic version of Pfizer Inc’s Zithromax and is indicated for mild to moderate infections caused by bacteria.
As per IMS MAT sales data, Zithromax Oral Suspension had US sales of $110.6 million.
Shares of Lupin today ended 1.21 per cent up at Rs 1,501.60 on BSE.