The US Food and Drug Administration has indicated it will approve a patch for treating attention deficit hyperactivity disorder in children, provided that the manufacturers agree to certain changes in how the ADHD patch will be labelled and agree to monitor the product once it is on the market.
Following up on our earlier article on the methylphenidate transdermal system for ADHD (“Success for New ADHD Patch”), it looks like the FDA is now set to approve an ADHD patch from Noven Pharmaceuticals and Shire Pharmaceuticals Group, which co-developed the patch:
In a letter to Noven Pharmaceuticals Inc., the Food and Drug Administration included proposed changes to how the patch is labeled, the Miami-based company said. The FDA also asked that the company clarify some data and conduct surveillance and study of the product once it is on the market. The patch would be sold under the name Daytrana.
Earlier this month, an FDA panel of independent experts voted to recommend that the patch’s label encourage its use as an alternative treatment for children between the ages of 6 and 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
The patch, which is designed to go on a child’s hip for a period of 9 hours, releases methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The ADHD patch will be marketed under the name ‘Daytrana’.
In 2003, Noven submitted a proposal for a 12-hour ADHD patch, but the FDA rejected it and recommended a 9-hour patch instead.
Please note: We have now closed the comment form for this article, but a new article about visitors’ reports of problems with the Daytrana ADHD patch is now available: “Problems With the Daytrana ADHD Patch?”. Please leave feedback there if you’d like to talk about your experiences with the patch!
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