Endo to respond to FDA questions on Fortesta by mid-2010

October 19, 2009 11:08 AM ET

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John George

Endo Pharmaceuticals said Monday it expects to respond to the Food and Drug Administration's questions about the company’s new drug application for the low testosterone treatment Fortesta by mid-2010.

Fortesta is an experimental gel product for men diagnosed with low testosterone, also known as hypogonadism.

Endo (NASDAQ:ENDP) of Chadds Ford, Pa., acquired the exclusive U.S. rights to the drug from ProStrakan Group of the United Kingdom in August in a deal valued at up to $200 million. Fortesta is marketed as Tostran, Tostrex and Itnogen outside the United States.

The FDA in September announced it was extending for up to three months its review of Endo’s new drug application for Fortesta. Endo did not provide the specific questions the agency had in its recently submitted complete response letter to the company’s new drug application.

In the United States, Fortesta’s competition, if ultimately approved, would include Testim, a testosterone gel which was developed and is marketed by Auxilium Pharmaceuticals Inc. (NASDAQ:AUX) of Malvern.

Hypogonadism, characterized by low testosterone levels, is a common yet largely under-recognized and undertreated condition that afflicts an estimated 13.8 million American men. Symptoms include erectile dysfunction, infertility and decrease in muscle mass.

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