Granules India Receives FDA Approval for Lisdexamfetamine Dimesylate Capsules, Expanding ADHD Portfolio

Granules India Limited, a vertically integrated Indian pharmaceutical company, announced that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Capsules in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. This generic drug product is bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse® Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg, of Takeda Pharmaceuticals U.S.A,, Inc. Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, as well as for Moderate to Severe Binge Eating Disorder (BED) in adults. This approval follows the company's recent December 2024 USFDA approval for Lisdexamfetamine Dimesylate Chewable Tablets, further expanding Granules' comprehensive portfolio in the ADHD therapeutic segment and demonstrating the company's commitment to providing multiple treatment options for patients.