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# Shire Gains Approval for ADHD Drug
- URL: https://www.fdaweb.com/shire-gains-approval-for-adhd-drug/
- Published: 2017-06-21T12:00:00.000Z
- Updated: 2026-09-14T22:30:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138987

FDA has approved a Shire NDA for Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment comprising three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Approval was based on data from 16 clinical studies evaluating the drug in more than 1,600 subjects. “In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance, in adults and adolescents,” the company says.