Granules India gets USFDA Approval for Generic ADHD Drug
Wednesday, 18 December 2024, 12:49 IST
Drug firm Granules India said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder.
Granules Pharmaceuticals, Inc. GPI announced that it has gotten approval from the U.S. Food and Drug Administration (USFDA) on its abbreviated new drug application (ANDA) on Lisdexamfetamine Dimesylate chewable tablets. The strengths of the approved product, according to the company, will be 10mg, 20mg, 30mg, 40mg, 50mg and 60mg.
The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said.
The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) 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 Ltd Chairman & Managing Director Krishna Prasad Chigurupati said.
Granules Pharmaceuticals, Inc. GPI announced that it has gotten approval from the U.S. Food and Drug Administration (USFDA) on its abbreviated new drug application (ANDA) on Lisdexamfetamine Dimesylate chewable tablets. The strengths of the approved product, according to the company, will be 10mg, 20mg, 30mg, 40mg, 50mg and 60mg.
The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said.
The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) 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 Ltd Chairman & Managing Director Krishna Prasad Chigurupati said.
