Daytrana

methylphenidate

Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System

MIAMI, December 13, 2005 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that it expects to commence the manufacture of launch supplies of Daytrana (methylphenidate transdermal system) this week.

Daytrana, licensed globally to Shire plc, is an investigational transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. An amended New Drug Application (NDA) for the product is currently pending at the U.S. Food and Drug Administration (FDA). The FDA regulatory review period under the Prescription Drug User Fee Act for Daytrana is scheduled to conclude December 28, 2005.

Earlier in December 2005, the U.S. Drug Enforcement Administration (DEA) granted Noven procurement quota (methylphenidate raw material) sufficient to manufacture launch supplies. Noven's application for additional procurement quota is currently pending at the DEA.

Source: Noven Pharmaceuticals, Inc.

Related Articles:

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

FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System - December 23, 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

Latest New Drug Applications...

Daily MedNews
Pharma Industry News
New Drug Applications
New Drug Approvals
Clinical Trial Results
Generic Drug Approvals