Wednesday, 19 December 2018

USFDA approves Glenmark’s pneumonia treatment drug

22 November 2018 | News

The approved drug is a generic version of GlaxoSmithKline's Mepron Oral Suspension of similar strength

Glenmark Pharmaceuticals said it has received final approval from the US health regulator for Atovaquone, used for prevention and treatment of a type 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 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.

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