Granules Pharmaceuticals gains U.S. FDA approval for Lisdexamfetamine Dimesylate chewable tablets

Granules India, through its wholly-owned foreign subsidiary Granules Pharmaceuticals (GPI), has received approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. The product, available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, is bioequivalent to Vyvanse Chewable Tablets by Takeda Pharmaceuticals USA.

The approved medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged six years and older, as well as Moderate to Severe Binge Eating Disorder (BED) in adults. Granules received approval in the first review cycle, underscoring its regulatory efficiency and focus on expedited product availability.

Lisdexamfetamine Dimesylate Chewable Tablets are currently listed on the FDA Drug Shortages List, highlighting their importance in addressing ongoing supply issues in the healthcare system.

Commenting on the development, Dr Krishna Prasad Chigurupati, Chairman and Managing Director of Granules, 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 U.S. healthcare market.”

This latest addition brings Granules India’s total ANDA approvals to 68, including 30 approvals secured through GPI.