New Drug Applications

Vyvanse

lisdexamfetamine dimesylate

Treatment for Attention Deficit Disorder

Update: Vyvanse Now FDA Approved - February 23, 2007

New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse

BASINGSTOKE, U.K., PHILADELPHIA and RADFORD, Va., December 21, 2006 -- New River Pharmaceuticals Inc. and its collaborative partner Shire plc 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 together to provide full and timely responses to the agency's request. The data requested are routine, and their provision to the FDA is not expected to delay a launch of Vyvanse in the second quarter of 2007. The U.S. Drug Enforcement Agency's parallel review of Vyvanse's scheduling assignment is expected within three months.

The FDA has proposed that Vyvanse be classified as a Schedule II controlled substance. This proposal has been submitted to the U.S. Drug Enforcement Administration (DEA). Once Vyvanse is approved by the FDA and receives final scheduling designation by DEA, Vyvanse will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

For more information about ADHD, please visit www.ShireADHDTreatments.com.

Source: Shire plc

Related Articles:

FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults - April 23, 2008

FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients - January 3, 2008

Shire Receives FDA Approval of Vyvanse for ADHD - February 26, 2007

FDA Issues Approvable Letter for NRP104 (lisdexamfetamine dimesylate) for the Treatment of ADHD - October 6, 2006

New River Pharmaceuticals Announces NRP104 NDA Accepted for Review - January 27, 2006

Shire Announces New River Pharmaceuticals Filing of NRP104 - December 7, 2005