Shire Pharmaceuticals gets FDA approval for Daytrana

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.”

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