The FDA approved Shire's for patients ages 13 and up, .
Shire notes that the approval is based on results from 16 studies in more than 1,600 patients, including both adolescents (ages 13 to 17) and adults -- and they've had plenty of time to gather that data. The drug was previously known as SHP465 and the FDA .
A lot has changed in that time, including Shire's prominence as a pharma company, and the market for ADHD meds, .
Mydayis is supposed to last 16 hours, qualifying it for once-daily dosing, although Shire's extended-release Adderall lasts just 4 hours less, up to 12 hours. The active ingredient in these products -- mixed amphetamine salts -- is readily available as a cheap generic.
Shire's ADHD portfolio also includes Vyvanse (lisdexamfetamine).
The FDA also approved another ADHD drug this week: Neos Therapeutics' orally disintegrating tablet formulation of extended-release methylphenidate (Cotempla XR-ODT).