DaytranaTreatment for Attention Deficit Hyperactivity Disorder (ADHD)
FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System
MIAMI, December 23, 2005 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter relating to Daytrana (methylphenidate transdermal system), a developmental product under FDA review for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. Daytrana is licensed globally to Shire plc.
In its letter, the FDA states that it has completed its review of the amended New Drug Application (NDA) for Daytrana and has determined that it is approvable. The approvable letter contains proposed revisions to labeling, as well as requests for data clarification, post marketing surveillance, and post-marketing studies.
"We are pleased that the FDA has determined that Daytrana is approvable for the treatment of ADHD," said Robert C. Strauss, Noven's President, CEO & Chairman. "Noven and Shire will be working with the FDA as necessary to address the remaining issues and to advance the NDA toward final approval."
If the product is ultimately approved, Noven will receive a $50 million milestone payment from Shire, and may 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: December 2005
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- Daytrana Approved - Shire plc - Treatment for Attention Deficit Hyperactivity Disorder - April 6, 2006
- FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response - March 10, 2006
- 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
- Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients - July 26, 2005