Granules India's Generic ADHD Drug Gets FDA Nod

Drug maker Granules India Ltd. announced on Tuesday that its subsidiary, Granules Pharmaceuticals Inc., has received approval from the US Food and Drug Administration for a generic version of a medication used to treat attention-deficit hyperactivity disorder.

The approval pertains to GPI's abbreviated new drug application for Lisdexamfetamine Dimesylate chewable tablets, the company said in an exchange filing. The generic product will be available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.

Granules has received approval in the first review cycle, the company added.

Granules India's product is the generic equivalent of Takeda Pharmaceuticals' Vyvanse chewable tablets, the regulatory filing added.

The medication is indicated for the treatment of attention deficit hyperactivity disorder in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder in adults.

Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising their critical role in patient care, it added.

"This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications," Granules Chairman and Managing Director Krishna Prasad Chigurupati said.

Granules India now holds 68 ANDA approvals, including 30 ANDAs from GPI.

Granules stock rose as much as 1.32% during the day to Rs 591.80 apiece on the NSE. The stock closed 0.97% higher at Rs 589.75 per share. This compares with a 1.35% decline in the benchmark Nifty 50. It has risen 46.59% in the last 12 months and 43.21% year-to-date.

All seven analysts tracking the company maintain a 'buy' rating, according to Bloomberg data. The average 12-month consensus price target implies an upside of 12%.

(With Inputs From PTI)