Granules India arm gets USFDA nod for ADHD drug

Drug firm Granules India Friday said its subsidiary has received marketing approval from the US health regulator for Dexmethylphenidate HCl extended-release capsules, used for the treatment of attention-deficit hyperactivity disorder (ADHD).

The approved product is bioequivalent to the reference listed drug Focalin XR of Novartis AG.

In a BSE filing, Granules said its US subsidiary has received marketing approval from the US Food and Drug Administration (USFDA) for Dexmethylphenidate HCl extended-release capsules.

The company said the newly approved drug will be manufactured at the Granules' manufacturing facility in Chantilly, Virginia.

Granules now have a total of 30 abbreviated new drug application (ANDA) approvals from the USFDA (28 final and 2 tentative).

Quoting IQVIA Health data, Granules said Dexmethylphenidate HCl extended-release capsules had US sales of approximately $556 million for the most recent 12 months ending in July 2020.

Shares of Granules India were trading 0.96 per cent higher at Rs 364.55 apiece on BSE.