Article: Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD.

ATLANTA -- Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD). In multi-center, placebo-controlled, double-blind, randomized Phase III clinical trials, Clonicel showed statistical significance when used to treat ADHD.

Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, "We are pleased that Addrenex has filed the sNDA with the FDA. Clonicel is an important product in our pediatric ...

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