Shire, New River ADHD drug gets second FDA approvable letter

12/22/06 - newratings.com

LONDON, December 22 (newratings.com) – UK-based pharmaceutical company Shire Plc (SHP-GBX) Friday announced that the US Food & Drug Administration (FDA) had issued a second approvable letter for its Attention Deficit Hyperactivity Disorder (ADHD) drug, Vynase.

The drug, formerly known as NRP-104, is being developed in collaboration with New River Pharmaceuticals Inc (NRPH). Shire said that the FDA has sought routine data related to the drug, which was expected to be launched in the second quarter of 2007. The two companies said that they will work together to provide full and timely responses to the FDA’s request. The final approval for the drug is contingent upon the restrictions imposed by the Drug Enforcement Administration.