New Delhi: Glenmark Pharmaceuticals Thursday said it has received final approval from the US health regulator for Atovaquone, used for prevention and treatment of a type of pneumonia. Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Atovaquone Oral Suspension USP in the strength of 750 mg/5 mL,” the company said in a BSE filing.
The approved drug is a generic version of GlaxoSmithKline’s Mepron Oral Suspension of similar strength.
Quoting IQVIA sales data, Glenmark said, Mepron Oral Suspension market achieved annual sales of approximately USD 119.1 million.
The company’s current portfolio consists of 144 products authorised for distribution in the US marketplace and 55 abbreviated new drug applications (ANDAs) pending approval with the USFDA.