Daytrana
Generic name: methylphenidate
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)
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.
Posted: December 2005
Related articles
- FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents - July 7, 2010
- 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
Daytrana (methylphenidate) FDA Approval History
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