Granules India receives US FDA approval for Amphetamine Sulfate tablets

The product is generic version of Arbor Pharmaceuticals LLC’s Evekeo tablets in similar strength

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

The US Food and Drug Administration (US FDA) 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.

By Press Trust of India

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