Endo Pharmaceuticals Holdings Inc. (ENDP) said Monday that the U.S. Food and Drug Administration has issued a Complete Reponse Letter for its New Drug Application of Fortesta 2% Gel for men diagnosed with low testosterone.
The FDA usually sends applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval.
Low testosterone or Low T, also known as hypogonadism, is a condition in men characterized by the body's failure to produce normal amounts of the hormone testosterone. Low T can lead to fatigue or low energy, decreased sexual function, and depressed mood.
Hypogonadism, though common, is largely under-recognized and under-treated condition. An estimated 13.8 million American men have testosterone levels characterized as below normal. Yet, only about 9% are treated with testosterone replacement therapy.
Endo Pharma noted that it will work closely with the FDA to address their questions. The company added that it will file its complete response by mid-2010.
In August, Endo signed an agreement with U.K.-based ProStrakan Group Plc to acquire exclusive U.S. rights to commercialize the testosterone 2% gel. Outside the U.S. it is branded variously as Tostran, Tostrex and Itnogen.
In Europe, ProStrakan would market testosterone 2% gel, through its in-house sales forces and has also out-licensed it to Bayer Schering Pharma (BSP) in 147 countries.
"The potential of this action was considered in the structure of the deal to in-license this product. Endo is committed to bringing FORTESTA to market to offer men another option for testosterone replacement therapy," commented Ivan Gergel, executive vice president, R&D, Endo Pharma.
ENDP is currently trading down 0.72% at $23.30, on the Nasdaq.
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