Published on October 19, 2009 at 9:33 AM
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.
SOURCE Endo Pharmaceuticals
ada22094-9147-4075-813a-5f27a5a1b2d2|0|.0
Posted in: Pharmaceutical News
Tags: Anti-Inflammatory, Cancer, Cardiovascular Disease, Diabetes, Endocrinology, Erectile Dysfunction, Metabolic Syndrome, Migraine, Neuralgia, Neurology, New Drug Application, Oncology, Osteoarthritis, Overactive Bladder, Prostate Cancer, Puberty, Testosterone, Urology, Voltaren