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Article: First depression patch approved.(Emsam from Bristol-Myers Squibb Co. approved)(Brief article)
- Article from:
- FDA Consumer
- Article date:
- May 1, 2006
CopyrightCOPYRIGHT 2006 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The FDA has approved the first skin (transdermal) patch, called Emsam (selegiline), for treating major depression.
Emsam is a once-a-day patch that delivers selegiline, a monoamine oxidase inhibitor, or MAOI, through the skin and into the bloodstream. Its three layers consist of a backing, adhesive drug layer, and release liner that is placed against the skin.
"Emsam provides a significant advance," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, "because at least in its lowest dose, patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors." The ...
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Article: Woodcock steps in at CDER as Galson departs.(WASHINGTON ...
Medical Marketing & Media;
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700+ words
... ... flounderings over product safety more than anything else provoked passage of the FDA Amendments Act. Drug center director Steven Galson was elevated to acting surgeon general. His predecessor, FDA deputy commissioner and chief medical officer Janet Woodcock ...
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