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FDA Calls For Black Box Warnings On AndroGel, Testim

Law360 (May 7, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration instituted new labeling procedures for two prescription testosterone gel products on Thursday, after receiving reports of inappropriate virilization in children who were exposed to the drugs.

Solvay Pharmaceuticals Inc., the makers of best-selling AndroGel, and Auxilium Pharmaceuticals Inc., the makers of Testim, will be required to include a boxed warning on the products’ labels, among other safety measures, the FDA announced.

Although labels for both gels warn users they must wash their hands after applying the product and cover exposed...
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