Tags: FDA | Panel | OKs | ADHD | Patch

FDA Panel OKs ADHD Patch

Friday, 02 December 2005 12:00 AM

A federal advisory panel says the first skin patch to treat attention deficit hyperactivity disorder (ADHD)in children is both effective and safe, bringing the patch a step closer to regulatory approval.

However, the panel of independent experts voted to recommend that the patch's label encourage its use only as an alternative treatment for children with ADHD - in effect suggesting that doctors should prescribe it only when taking pills is too difficult for a child.

The unanimous vote by the FDA's Psychopharmacologic Drugs Advisory Committee, saying the patch was acceptably safe, came after a formerly critical reviewer reversed his opinion.

The agency must now decide whether or not to approve the patch - but it usually follows the advice of its advisory committees.

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A federal advisory panel says the first skin patch to treat attention deficit hyperactivity disorder (ADHD)in children is both effective and safe, bringing the patch a step closer to regulatory approval. However, the panel of independent experts voted to recommend that...
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2005-00-02
Friday, 02 December 2005 12:00 AM
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