Granules Pharmaceuticals, Inc. has successfully received USFDA approval for its bioequivalent generic version of Lisdexamfetamine Dimesylate Chewable Tablets in various strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. This generic version corresponds to Vyvanse® Chewable Tablets by Takeda Pharmaceuticals USA Inc.
Approved Indications:
- Attention Deficit Hyperactivity Disorder (ADHD):
- For adults and children aged 6 years and above.
- Moderate to Severe Binge Eating Disorder (BED):
- For adults only.
Approval achieved in the first review cycle, showcasing the company’s commitment to regulatory excellence and accelerated market readiness.This approval strengthens Granules’ portfolio of generic formulations in the central nervous system (CNS) therapeutic area.
This milestone reflects the company’s efforts to expand access to cost-effective treatments for ADHD and BED.