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Daytrana Approval History

  • FDA approved: Yes (First approved April 6th, 2006)
  • Brand name: Daytrana
  • Generic name: methylphenidate
  • Dosage form: Transdermal System
  • Previous name: MTS
  • Company: Shire Pharmaceuticals Group plc / Noven Pharmaceuticals, Inc.
  • Treatment for: ADHD

Daytrana is a once daily transdermal patch formulation of methylphenidate indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

Development History and FDA Approval Process for Daytrana

Jul  7, 2010Approval FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents
Apr  6, 2006Approval Daytrana Approved - Shire plc - Treatment for Attention Deficit Hyperactivity Disorder
Mar 10, 2006FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response
Dec 23, 2005FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System
Dec 13, 2005Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System
Dec  2, 2005Noven Announces Results of Daytrana Advisory Committee Meeting
Oct 27, 2005Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review
Jul 26, 2005Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients

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