Granules India Gets USFDA Nod For Capsules That Treat ADHD

Pharmaceuticals firm, Granules India Ltd on Thursday said its arm has received a final nod from the US health regulator for its generic version of Lisdexamfetamine Dimesylate capsules indicated for the treatment of attention deficit hyperactivity disorder.

The approval granted by the US Food & Drug Administration (USFDA) to Granules Pharmaceuticals, Inc is for the 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, Granules India said in a regulatory filing.

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, Inc, it added.

The company said Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older, as well as for moderate to severe Binge Eating Disorder in adults.

With this latest approval, we are reinforcing our presence in the ADHD treatment space and strengthening our portfolio of complex generics,' Granules India Chairman And Managing Director Krishna Prasad Chigurupati said.

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..., the company added.