Drug firm Granules India Tuesday said its subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride extended-release tablets used in the treatment of a sleep disorder called narcolepsy.
The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc, subsidiary of Granules India Ltd, through its US agent First Time US Generics LLC, for Methylphenidate Hydrochloride extended-release tablets USP, 10 mg and 20 mg, Granules India said in a filing to BSE.
The approved product is the therapeutic equivalent of the reference listed drug Ritalin SR sustained-release tablets 20 mg of Novartis Pharmaceuticals Corporation, it added.
The company said Granules Pharmaceuticals Inc shall market and distribute the product shortly.
Shares of Granules India were trading at Rs 90 apiece, down 0.61 per cent from previous close, on BSE.