Glenmark Pharma gets USFDA approval for Amphetamine Sulfate Tablets

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals.

The tablets are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, a sleeping disorder.

According to IQVIA sales data for the 12 month period ending November 2020, the Evekeo Tablets, 5 mg and 10 mg market achieved annual sales of approximately $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 US FDA.