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The pharmaceutical company, in an exchange filing on Tuesday, said its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has been granted approval from the US health regulator for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets.
The drug is made available in multiple strengths, including 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
The approved ANDA is determined to be a bioequivalent or AB Rating (therapeutic equivalent) to the reference listed drug (RLD), Vyvanse chewable tablets by the pharmaceutical company, Takeda Pharmaceuticals USA Inc.
The Lisdexamfetamine Dimesylate chewable tablets are prescribed medication for treating Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older.
The tablets are also indicated for the treatment of Moderate to Severe Binge Eating Disorder (BED) in adults, Granules India said in a press release on December 17, 2024.
Granules has received approval in the first review cycle, and the Lisdexamfetamine Dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising the drug’s critical role in patient care.
The Hyderabad-based company has now received a total of 68 ANDA approvals from the USFDA.
“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,” stated the Chairman and Managing Director of Granules India, Dr. Krishna Prasad Chigurupati.
Shares of the pharma company gained almost a percent on Tuesday and were seen trading on a muted note, up 0.4% to ₹587 per piece on the BSE at 12 pm.
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