FDAnews Device Daily Bulletin

FDA OFFICIAL FROWNS ON PATCH FOR ADHD

Dec. 2, 2005
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A new treatment for hyperactive kids, one that uses a skin patch instead of a pill, is meeting resistance with regulators. Noven Pharmaceutical, a Miami-based drug maker specializing in skin patches, is awaiting a regulatory decision on Methypatch, a treatment for attention-deficit hyperactivity disorder for children ages 6 to 12. But Noven got some bad news from the Food and Drug Administration Thursday morning. Dr. Robert Levin, director of the FDA's division of psychiatry products, wrote that Methypatch is effective in treated ADHD but "cannot be safely marketed, even the with nine-hour wear time," according to documents released by the FDA Thursday.

CNN/Money (http://money.cnn.com/2005/12/01/news/midcaps/adhd/index.htm?section=money_latest)