Shire Pharmaceuticals has received an approvable letter from the US Food and Drug Administration for Daytrana (methylphenidate transdermal system), an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years.
According to a company release, 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. 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," said Shire chief executive officer Matthew Emmens.
Shire and Noven Pharmaceuticals, Inc. submitted an amended new drug application (NDA) for Daytrana to the FDA in June of this year. Daytrana is licensed globally to Shire by Noven.