The patch, known as Daytrana, was licensed to Shire from its original developers Noven Pharmaceuticals, and is under review to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years.
The advisory committee recommendation appears to reverse a recommendation made last week when safety concerns lead the committee to suggest that the patch should not be approved.
However, the advisory committee has now voted unanimously that the patch is both effective and safe. Although the committee did recommend that post-marketing surveillance and/or studies related to the product should be undertaken.
The committee also advised that the packaging should include the recommendation that the patch should only be used by children who have trouble taking oral treatments for ADHD, however the committee rejected a proposal by eleven votes to one to formally limit the usage of the patch along these lines.
“We are pleased that the Advisory Committee voted in favor of Daytrana’s safety and efficacy in children diagnosed with ADHD,” said Shire CEO, Matt Emmens. “This delivery option can provide a much needed alternative for parents and physicians to help children living with ADHD.”