Oct. 19, 2009 (PR Newswire) --
CHADDS FORD, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.
"The potential of this action was considered in the structure of the deal to in-license this product," said Dr. Ivan Gergel, M.D., executive vice president, R&D, Endo Pharmaceuticals. "We will continue to work closely with the FDA to address their questions and we expect to file a complete response, mid-2010. Endo is committed to bringing FORTESTA to market to offer men another option for testosterone replacement therapy."
In August 2009, Endo signed an agreement with U.K.-based ProStrakan Group Plc to acquire exclusive U.S. rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside the U.S. The testosterone 2% gel is marketed across Europe by ProStrakan's own, in-house sales forces and is out-licensed by ProStrakan to Bayer Schering Pharma (BSP) in 147 countries.
LOW T
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. It is associated with symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction. In addition, there is increasing evidence of the link between Low T and other serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome. Because the symptoms of Low T are often similar to those caused by other medical conditions, more than 91 percent of men with the condition go undiagnosed.
About Endo
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP).
