Granules gets USFDA nod for ADHD drug

Granules gets USFDA nod for ADHD drug
Highlights

Drug firm Granules India on Monday said its subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride

Hyderabad: Drug firm Granules India on Monday said its subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride extended-release capsules, used for the treatment of attention deficit hyperactivity disorder (ADHD).

The approved product is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis Pharmaceuticals Corporation.

The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India, for Methylphenidate Hydrochloride extended-release capsules in the strengths of 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, Granules said.

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