Endo Pharmaceuticals' Gel for Low Testosterone Wins FDA Marketing Approval

Endo Pharmaceuticals Holdings Inc., the maker of pain medications, won U.S. approval to sell Fortesta, a testosterone replacement therapy for men.

The Food and Drug Administration cleared the drug, a transdermal gel that contains 2 percent testosterone, the company said today in a statement.

Endo, based in Chadds Ford, Pennsylvania, will market the drug for men with low testosterone. The condition, known as hypogonadism, can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota. Endo licensed Fortesta in August 2009 from ProStrakan Group Plc, based in Galashiels, Scotland. The drug is sold in Europe under the names Tostran, Tostrex and Itnogen.

“The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems,” Adrian Dobs, a professor at Johns Hopkins University School of Medicine in Baltimore, and a principal investigator of the drug’s late- stage trial, said in Endo’s statement. “Fortesta gel is an important new treatment option for men who are diagnosed with low testosterone.”

Endo plans to begin selling the treatment in early 2011, the company said in its statement.

Endo increased 4.9 percent at 4:28 p.m. New York time in extended trading after gaining 1 cent to $35.22 at the close of Nasdaq Stock Market composite trading. The shares have increased 72 percent this year.

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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