Indevus submits NDA for Nebido to US FDA

The USA's Indevus Pharmaceuticals says that the Food and Drug Administration has accepted for review its New Drug Application for Nebido, a long-acting depot preparation of testosterone undecanoate for the treatment of male hypogonadism. The FDA action date for the agent is now set for June 27, 2008.

The NDA contains data from six clinical studies in which over 400 patients received at least one dose of Nebido, with over 300 of these patients treated for more than one year. In total, over 3,000 injections of the drug have been given to hypogonadal males during the clinical development program. In addition, the NDA includes post-marketing data from safety reporting through June 2007, reflecting the world-wide experience from over 260,000 injections of the product.

According to the firm, Nebido is expected to be the first three-month testosterone preparation available in the USA in the growing market for testosterone therapies. Indevus acquired domestic rights to the agent from Germany's Bayer Schering Pharma AG in July 2005.