Lisdexamfetamine Dimesylate is indicated for the treatment of ADHD in adults and pediatric patients aged six years and older, as well as for Moderate to Severe Binge Eating Disorder (BED) in adults

Granules India's wholly-owned foreign subsidiary, Granules Pharmaceuticals has received final approval from the US 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 USA. 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.

Dr Krishna Prasad Chigurupati, CMD, Granules India, said, “With this latest approval, we are reinforcing our presence in the ADHD treatment space and strengthening our portfolio of complex generics.”