Granules Pharma receives US FDA approval

Granules Pharma receives US FDA approval

Agency News

Mumbai, Aug 6 : Granules Pharmaceuticals said that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc.,a wholly owned foreign subsidiary of Granules India Limited for Amphetamine Sulfate Tablets USP 5 mg and 10 mg.

It is bioequivalent to the reference listed drug product (RLD), Evekeo Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

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).(UNI)