Granules India has informed 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 the company 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).
The above information is a part of company’s filings submitted to BSE.
