India, Dec. 22 -- Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets.
The approval covers multiple strengths ranging from 3.1 mg to 18.8 mg and is the generic equivalent of ADZENYS XR-ODT®. The product will be manufactured at Granules' US-based facility in Chantilly, Virginia.
The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA data, the product has an estimated market size of around USD 172 million. At present, the market has only one approved generic and...