Endo Pharmaceuticals and its majority-owned subsidiary Indevus Pharmaceuticals have said that the US Food and Drug Administration (FDA) has accepted for review the complete response submission to the new drug application (NDA) for NEBIDO(R) (testosterone undecanoate) intramuscular injection.

NEBIDO,  an investigational testosterone preparation for the treatment of male hypogonadism, is a long-acting injectable testosterone preparation for the treatment of male hypogonadism. Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, erectile dysfunction, muscle loss and weakness, depression, as well as an increased risk of osteoporosis.

NEBIDO was licensed by BayerSchering Pharma AG to Indevus Pharmaceuticals, a majority interest in which Endo acquired earlier this year. If approved, NEBIDO is expected to be the first long-acting testosterone preparation available in the US in the growing market for testosterone replacement therapies. NEBIDO is currently marketed by BayerSchering and its partners in Europe and other territories.

FDA is targeting September 2, 2009 as the action date for a decision on this application.