USFDA22 Dec 2025, 07:44 am
Granules Pharmaceuticals Inc. Receives FDA Tentative Approval for Generic Amphetamine Extended-Release Orally Disintegrating Tablets
AI Summary
Granules Pharmaceuticals Inc., a subsidiary of Granules India Limited, 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 product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 172 million. The approval positions Granules favourably to expand access to this critical therapy upon launch.
Key Highlights
- Granules Pharmaceuticals Inc. receives Tentative Approval from the U.S. FDA for Amphetamine Extended-Release Orally Disintegrating Tablets
- The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
- The estimated market size of the product is approximately USD 172 million
- Granules is the second company to receive approval for this generic version
- The product will be manufactured at Granules’ US-based facility located in Chantilly, Virginia