US FDA delays Endo Pharma's testosterone gel approval

Endo Pharmaceuticals announced that it received a Complete Response letter from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Fortesta (testosterone) 2 per cent gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.

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 UK-based ProStrakan Group Plc to acquire exclusive US rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside the US. 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.