Granules India Receives USFDA Approval for Lisdexamfetamine Dimesylate Chewable Tablets, Addressing Drug Shortages in the U.S.

Granules India Limited, a vertically integrated Indian pharmaceutical company, announced that its 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. The approved drug is available in multiple strengths and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Moderate to Severe Binge Eating Disorder (BED). Granules has received approval in the first review cycle, reflecting the company’s focus on regulatory excellence and expedited product delivery. The drug is currently on the FDA Drug Shortages List, highlighting its importance in patient care.