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# FDA Approves Dyanavel XR ADHD Tablets
- URL: https://www.fdaweb.com/fda-approves-dyanavel-xr-adhd-tablets/
- Published: 2021-11-05T12:00:00.000Z
- Updated: 2026-09-14T17:21:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150530

FDA has approved a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit hyperactivity disorder (ADHD) in patients six years and older. Approval was based on data showing that DyanaveL XR extended-release tablets were bioequivalent to the company’s Dyanavel XR extended-release oral suspension, according to Tris Pharma. Clinical data also demonstrated ADHD symptom improvement within one hour, which lasted through 13 hours after once-daily dosing.