"Granules India Limited, a vertically integrated Indian pharmaceutical company, announced that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lisdexamfetamine dimesylate chewable tablets. The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. The company now holds 68 ANDA approvals, including 30 ANDAs from GPI.
This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse chewable tablets by Takeda Pharmaceuticals USA Inc. Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and paediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults.
Hyderabad-based Granules has received approval in the first review cycle, reflecting the company’s consistent focus on regulatory excellence and expedited product delivery. Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasizing their critical role in patient care.
Commenting on the approval, Dr Krishna Prasad Chigurupati, chairman & managing director of Granules Limited, said, "This milestone reflects our unwavering 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 US healthcare market."