A decade behind schedule, Shire finally gets an FDA OK for long-acting ADHD drug
It took a decade longer than Shire had originally bargained on, but the biotech has finally landed FDA approval of its long-acting ADHD drug SHP465.
The drug — to be sold as Mydayis — uses the same active ingredient as generic Adderall XR but extends the mainstay drug’s effective reach from 12 hours to 16, making it a one pill per day treatment.
Payers have become particularly skillful at setting up hurdles for generic makeovers, but Shire ran new trials last year to come up with the safety and efficacy data that the agency originally demanded after it was submitted in 2006.
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