Drug major Glenmark Pharma on Thursday said it has received final approval from the US health regulator for central nervous system stimulant drug Amphetamine Sulfate tablets.
The approved product is a generic version of Evekeo tablets of Arbor Pharmaceuticals LLC.
Glenmark Pharmaceuticals Ltd has been granted final approval by the United States Food and Drug Administration (USFDA) for Amphetamine Sulfate tablets USP in the strengths of 5 mg and 10 mg, it said in a regulatory filing.
Quoting IQVIA sales data for the 12 month period ending November 2020, Glenmark said Evekeo Tablets, 5 mg and 10 mg market achieved annual sales of approximately USD 21.5 million.
Glenmark''s current portfolio consists of 168 products authorised for distribution in the US marketplace and 43 ANDA''s pending approval with the USFDA.