Granules gets U.S. FDA nod for generic version of Takeda’s ADHD drug

Granules India gains FDA approval for generic Vyvanse chewable tablets, addressing ADHD and BED drug shortages.

Granules India has received U.S. Food and Drug Administration approval for Lisdexamfetamine Dimesylate chewable tablets, its generic version of Takeda Pharmaceuticals’ central nervous system stimulant Vyvanse chewable tablets indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and moderate to severe binge eating disorder (BED).

Lisdexamfetamine Dimesylate chewable tablets currently figure in the FDA Drug Shortages List, the Hyderabad-based Granules on Tuesday said in a release on the abbreviated new drug application (ANDA) of subsidiary Granules Pharmaceuticals, Inc. receiving the U.S. FDA approval.

The generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug Vyvanse chewable tablets by Takeda Pharmaceuticals USA Inc. The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.

Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of ADHD in adults and paediatric patients aged six years and older as well as BED in

adults. Granules received the approval in the first review cycle, reflecting its consistent focus on regulatory excellence and expedited product delivery, the company said. “This milestone reflects our commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI reinforces its dedication to alleviating critical drug shortages in the U.S. healthcare market,” Granules Krishna Prasad Chigurupati said.

Granules India shares rose almost 1% to ₹589.70 each on the BSE.