Granules India Limited, a leading Indian pharmaceutical company, has announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. This approval covers multiple strengths, including 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
The generic version of Lisdexamfetamine Dimesylate has been deemed bioequivalent (AB Rating) to Vyvanse® Chewable Tablets by Takeda Pharmaceuticals USA Inc. It is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six and older, as well as Moderate to Severe Binge Eating Disorder (BED) in adults.
Granules India received approval in the first review cycle, demonstrating its commitment to regulatory excellence and swift market delivery. Lisdexamfetamine Dimesylate Chewable Tablets are currently listed on the FDA Drug Shortages List, underscoring their vital role in patient care.
Dr Krishna Prasad Chigurupati, Chairman & Managing Director of Granules Limited, stated, “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.”
With this approval, Granules India now holds 68 ANDA approvals, including 30 from GPI, further strengthening its position in the global pharmaceutical market.
