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Granules India’s arm gets USFDA approval for Amphetamine Sulfate tablets

PTI New Delhi | Updated on August 06, 2019 Published on August 06, 2019

Drug firm Granules India on Tuesday said its US arm has received approval from the USFDA for a generic central nervous system stimulant drug- Amphetamine Sulfate tablets.

The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by company’s subsidiary, Granules Pharmaceuticals Inc, for Amphetamine Sulfate tablets USP 5 mg and 10 mg, Granules India said in a filing to BSE.

The product is a generic version of Arbor Pharmaceuticals LLC’s Evekeo tablets in similar strength, it added.

“Amphetamine Sulfate tablets is a central nervous system stimulant used to treat sleep disorder, increase attention, decrease impulsiveness and hyperactivity in patients with Attention Deficit Hyperactivity Disorder (ADHD),” Granules India said.

Shares of Granules India were trading at ₹91.50 per scrip on BSE, up 2.12 per cent from its previous close.

Published on August 06, 2019
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