Friday, January 7, 2011

Testosterone Update


FDA approves Endo Pharmaceuticals' gel for low testosterone.

Bloomberg News (12/30, Peterson) reports, "Endo Pharmaceuticals Holdings Inc., the maker of pain medications, won US approval to sell Fortesta, a testosterone replacement therapy for men." The Food and Drug Administration approved "the drug, a transdermal gel that contains two percent testosterone." Low testosterone can cause "erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic."
The AP (12/30, Perrone) reports, "Drug companies are increasingly targeting low testosterone as a potential new market opportunity." Approximately "14 million American men are believed to have irregularly low testosterone levels, though only 1.3 million are being treated, according to the company." The article notes, "The FDA has placed warnings on all testosterone gels about the risks if the formulas rub off on children. Fortesta's label will include the same warning, which states: 'Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products.'" Dow Jones Newswire (12/30, Solsman, subscription required) also reports the story.

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