Glenmark Pharma receives US regulatory approval for Amphetamine Sulfate tablets

The shares of Glenmark Pharmaceuticals were trading in green during Thursday’s morning trading session after the company announced that it has received final approval by United States Food & Drug Administration (USFDA) for Amphetamine Sulfate tablets USP, 5 mg & 10 mg.  

The drug is a generic version of Evekeo 1 tablets, 5 mg & 10 mg of Arbor Pharmaceuticals. It is used to treat a sleep disorder called narcolepsy and also, to help increase attention and decrease impulsiveness & hyperactivity in patients with attention deficit hyperactivity disorder (ADHD).  

According to data from IMS Health, Evekeo tablets in the strengths of 5 mg and 10 mg achieved annual sales of US$ 21.5 million for the 12-month period ending November 2020.   

Glenmark’s current portfolio consists of 168 products authorised for distribution in the US marketplace along with 43 ANDA pending approvals with USFDA. 

At 11 am on Thursday, the stock of Glenmark Pharmaceuticals was trading at Rs 488.65, up by 0.65 per cent or 3.15 per share. The 52-week high is recorded at Rs 572.70 while its 52-week low is Rs 168 on BSE.