Vyvanse
lisdexamfetamine dimesylate
Treatment for Attention Deficit DisorderNew River Pharmaceuticals Announces NRP104 NDA Accepted for Review
RADFORD, Va., January 27, 2006 -- New River Pharmaceuticals Inc. announced that on January 26, the U.S. Food and Drug Administration accepted for review the Company's new drug application (NDA) for NRP104. New River submitted the NDA on December 6, 2005, seeking approval to manufacture and market the investigational compound for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric populations (ages 6-12). NRP104 is the subject of a collaborative development and commercialization agreement between New River and Shire plc .
"We are pleased that this NDA has been accepted for review," commented Suma Krishnan, New River's Vice President, Product Development. "This represents a key milestone in NRP104's regulatory development. We remain hopeful that this promising drug candidate will be approved and launched by the end of 2006."
The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review. It does not represent any opinion regarding the safety, efficacy or approvability of NRP104.
Source: New River Pharmaceuticals Inc.
Related Articles:
FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults - April 23, 2008
Shire Receives FDA Approval of Vyvanse for ADHD - February 26, 2007
New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse - December 21, 2006
FDA Issues Approvable Letter for NRP104 (lisdexamfetamine dimesylate) for the Treatment of ADHD - October 6, 2006
Shire Announces New River Pharmaceuticals Filing of NRP104 - December 7, 2005
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