Kinkini Gupta
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US FDA Approves The Use Of Chewable Tablets Meant To Treat ADHD And BED
The U.S. Food and Drug Administration has approved the use of Lisdexamfetamine Dimesylate chewable tablets, its generic version of Takeda Pharmaceuticals' central nervous system stimulant Vyvanse chewable tablets indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and moderate to severe binge eating disorder (BED). This approval was given to granules India.
Lisdexamfetamine Dimesylate chewable tablets are currently listed on the FDA Drug Shortages List, as announced by Hyderabad-based Granules on Tuesday. This update follows the approval of the abbreviated new drug application (ANDA) for its subsidiary, Granules Pharmaceuticals, Inc., by the U.S. FDA.
The drug is made available in multiple strengths to treat ADHD including 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. The approved ANDA has been deemed bioequivalent, or therapeutically equivalent (AB Rating), to the reference listed drug (RLD), Vyvanse chewable tablets, manufactured by Takeda Pharmaceuticals USA Inc. The Lisdexamfetamine Dimesylate chewable tablets are prescribed medication for treating Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older. The USFDA had approved a total of 68 ANDA for the Hyderabad-based company.
According to news reports, the Chairman and Managing Director of the drug company said in a statement, "This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI reinforces its dedication to alleviating critical drug shortages in the U.S. healthcare market."