Granules India Secures USFDA Nod for ADHD Generic Drug

Granules India's subsidiary, Granules Pharmaceuticals Inc, has received approval from the USFDA for its generic version of Lisdexamfetamine Dimesylate chewable tablets, used for ADHD and binge eating disorder. The drug provides a cost-effective alternative to Takeda Pharmaceuticals' Vyvanse and is listed on the FDA Drug Shortages List.

Drug firm Granules India announced on Tuesday that its subsidiary, Granules Pharmaceuticals Inc, has secured approval from the US health regulator to produce a generic medication for treating attention-deficit hyperactivity disorder (ADHD).

The US Food & Drug Administration (USFDA) has greenlit the abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, according to the company’s statement.

This medication, a cost-saving equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, is approved for both ADHD and moderate to severe binge eating disorder in multiple strengths and is currently listed on the FDA Drug Shortages List, highlighting its essential role in patient care.

(With inputs from agencies.)