New River Pharmaceuticals and Shire Receive Approvable Letter for VYVANSE(TM) (lisdexamfetamine dimesylate) for the Treatment of ADHD.
PR Newswire Europe, December, 2006
BASINGSTOKE, England, PHILADELPHIA and RADFORD, Virginia, December 22 /PRNewswire/ --
- Launch Expected Q2 2007
New River Pharmaceuticals Inc. (Nasdaq: NRPH) and its collaborative partner Shire plc (LSE: SHP, Nasdaq: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). On October 6, 2006 the FDA issued an approvable letter for VYVANSE and New River Pharmaceuticals submitted a complete response to the FDA on October 24, 2006.
No additional studies have been requested by the FDA as a condition for approval of VYVANSE. The companies will work...
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