Granules India Limited, through its wholly-owned foreign subsidiary Granules Pharmaceuticals, Inc. (GPI), secured final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Lisdexamfetamine Dimesylate Capsules in strengths ranging from 10 mg to 70 mg. This approval marks a significant addition to its ADHD portfolio, complementing its earlier approval in December 2024 for Lisdexamfetamine Dimesylate Chewable Tablets.
The newly approved capsules are bioequivalent and therapeutically equivalent to Vyvanse® Capsules by Takeda Pharmaceuticals and are indicated for the treatment of ADHD in adults and children aged six and above, as well as for Moderate to Severe Binge Eating Disorder in adults.
This development boosts Granules India’s complex generics segment and increases its total ANDA approvals to 69, with 38 under the parent company and 31 through GPI. Chairman and Managing Director, Dr. Krishna Prasad Chigurupati, highlighted this milestone as a reinforcement of the company’s strategic focus on expanding treatment options within the ADHD market.
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