FDA gives a tentaive nod to Lupin arm, Gavis Pharma's anti-bacterial drug
New Delhi : Drug firm Lupin 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 USD 110.6 million.