Shire gets FDA approval for new ADHD drug

02/24/07 - newratings.com

LONDON, February 24 (newratings.com) – UK-based pharmaceutical company Shire Plc (SHP-GBX) Friday announced that the US FDA had granted the marketing approval for Vyvnase, a new treatment for Attention Deficit Hyperactivity Disorder (ADHD).

Shire said the FDA had asked Vyvnase to be classified as a schedule II controlled substance. Shire expects the new treatment to replace its existing ADHD drug Adderall XR, which is due to lose patent protection in 2009. The company said it plans to launch Vyvanse in the second quarter of 2007 in three dosage strengths of 30mng, 50mg and 70mg. Shire had last week announced that it will gain full control of Vyvnase by acquiring its US partner New River Pharmaceuticals for $2.6 billion.