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.
"The potential of this action was considered in the structure of the deal to in-license this product," said Dr Ivan Gergel, 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 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.
Endo Pharma 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).