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Granules India’s ADHD drug approved by USFDA
The medication, a generic equivalent of Takeda Pharmaceuticals' Vyvanse chewable tablets, is used to treat attention-deficit hyperactivity disorder (ADHD) and moderate to severe binge eating disorder (BED).
Shares of Granules India saw a slight uptick following the announcement, trading 0.74 percent higher at USD$6.93 (₹588.65) apiece on the Bombay Stock Exchange (BSE). / Granules India
Granules India announced on Dec.17 that its US-based subsidiary, Granules Pharmaceuticals Inc. (GPI), has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets.
The medication, a generic equivalent of Takeda Pharmaceuticals' Vyvanse chewable tablets, is used to treat attention-deficit hyperactivity disorder (ADHD) and moderate to severe binge eating disorder (BED).
The tablets, approved in multiple strengths (10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg), are indicated for adults and pediatric patients aged six years and older. Notably, Lisdexamfetamine Dimesylate chewable tablets are currently listed on the FDA's Drug Shortages List, underscoring their importance in addressing critical patient care needs.
“This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications,” said Krishna Prasad Chigurupati, chairman and managing director of Granules India.
Granules India had previously expanded its footprint in the United States by inaugurating a facility in Virginia in March last year.
Shares of Granules India saw a slight uptick following the announcement, trading 0.74 percent higher at USD$6.93 (₹588.65) apiece on the Bombay Stock Exchange (BSE).
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