FDAnews Drug Daily Bulletin

FDA DECISION ON NOVEN'S ADHD PATCH EXPECTED IN APRIL

March 22, 2006
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Shire and Noven Pharmaceuticals expect the FDA to make a decision next month on the Daytrana investigational transdermal patch to treat attention-deficit/hyperactivity disorder (ADHD).

The FDA has assigned an April 9 date to complete its review of a resubmitted new drug application, the firms announced recently. The FDA had issued Shire and Noven an approvable letter in December 2005, but asked the companies to provide additional data before Daytrana (methylphenidate) could receive final regulatory approval. Shire licenses the product from Noven.

The approvable letter was issued shortly after the FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously to recommend approval for Daytrana. Although the panel determined Daytrana is both safe and effective, it urged the FDA to limit the drug's use, which is designed for once-daily use to treat ADHD in children ages 6-12.