Granules India has received U.S. Food and Drug Administration approval for 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).
Lisdexamfetamine Dimesylate chewable tablets currently figure in the FDA Drug Shortages List, the Hyderabad-based Granules on Tuesday said in a release on the abbreviated new drug application (ANDA) of subsidiary Granules Pharmaceuticals, Inc. receiving the U.S. FDA approval.
The generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug Vyvanse chewable tablets by Takeda Pharmaceuticals USA Inc. The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. Read more
Source: The Hindu