Granules India gets USFDA nod for generic drug

Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement.

The approved drug is available in multiple strengths; 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, it added.

The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said.


The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults.

Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising their critical role in patient care, it added.

"This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications," Granules Ltd Chairman & Managing Director Krishna Prasad Chigurupati said.

Shares of Granules India were trading 0.74 per cent up at Rs 588.65 apiece on BSE.