Home » News » 12/05 » Shire Pharmaceuticals gets FDA approval for Daytrana

Shire Pharmaceuticals gets FDA approval for Daytrana

Date published: 28/12/2005

Shire Pharmaceuticals has announced it has received an approvable letter from the US Food and Drug Administration (FDA) for Daytrana (methylphenidate transdermal system).

Daytrana is an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged six to 12 years.

The approvable letter contains proposed labelling, as well as requests for data clarification, post-marketing surveillance, and post-marketing studies. Shire is now initiating dialogue with FDA to address these issues.

"This approvable letter for Daytrana is positive news for Shire and our partner, Noven Pharmaceuticals," said Shire chief executive officer Matthew Emmens.

"We look forward to working with the FDA to agree on the final labelling for Daytrana. As the first and only non-oral medication for ADHD, Daytrana, if ultimately approved, will be a welcome new alternative to current therapies for patients diagnosed with ADHD."

© Adfero Ltd

Disclaimer

AllAboutMedicalSales excludes any warranty, express or implied, as to the quality, accuracy, timeliness, completeness or fitness for a particular purpose of this briefing. AllAboutMedicalSales will not be liable for any claims, penalties, losses, damages, costs, or expenses arising from the use of or inability to use this briefing or from any unauthorised access to or alteration of the Briefing. AllAboutMedicalSales makes no warranty that the contents of this briefing are compatible with all computer systems and browsers.