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# Adlon Therapeutics ADHD Drug Approved
- URL: https://www.fdaweb.com/adlon-therapeutics-adhd-drug-approved/
- Published: 2019-03-01T12:00:00.000Z
- Updated: 2026-09-15T01:08:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143509

FDA has approved an Adlon Therapeutics 505(b)(2) NDA for Adhansia XR (methylphenidate hydrochloride) extended-release capsules for treating attention-deficit/hyperactivity disorder in patients six years and older. In a simulated adult workplace environment study, Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8, 11, and 16 hours post-dose, but not at hour 14 post-dose, the company says. Adhansia XR will be available in six capsule strengths (25, 35, 45, 55, 70, and 85 mg), allowing for flexible dosing. Methylphenidate is a prescription stimulant and a federally controlled substance (schedule CII) that has a high potential for abuse and dependence, Adlon says.