Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, the generic equivalent of ADZENYS XR-ODT®. It will be manufactured at Granules' US-based facility located in Chantilly, Virginia.
The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 172 million according to IQVIA (IMS Health).
Currently, the market has only one approved generic and one authorised generic, positioning Granules favourably to expand access to this critical therapy upon launch. |