DaytranaTreatment for Attention Deficit Hyperactivity Disorder (ADHD)
FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response
MIAMI, March 10, 2006 - Noven Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has declared the February resubmission to the pending New Drug Application for Daytrana (methylphenidate transdermal system) to be a complete Class I response to the approvable letter previously issued by the FDA for the product. The FDA has assigned April 9, 2006 as the user fee goal date for the FDA to complete its review of the resubmission.
Daytrana, licensed globally to Shire plc, is a developmental product for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. The resubmission is intended to address the issues presented by the FDA in the December 23, 2005 Daytrana approvable letter, which included proposed revisions to labeling, as well as requests for data clarification, post-marketing surveillance, and post-marketing studies.
If Daytrana is ultimately approved, Noven would be entitled to receive a $50 million milestone payment from Shire, and would have the opportunity to earn additional milestone payments of up to $75 million depending on the level of Shire's commercial sales of the product. In addition, Noven expects to earn a profit on the manufacture and supply of finished product to Shire.
Daytrana is a trademark of Shire.
Source: Noven Pharmaceuticals, Inc.
Posted: March 2006
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- Daytrana Approved - Shire plc - Treatment for Attention Deficit Hyperactivity Disorder - April 6, 2006
- FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System - December 23, 2005
- Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System - December 13, 2005
- Noven Announces Results of Daytrana Advisory Committee Meeting - December 2, 2005
- Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review - October 27, 2005
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