FDA accepts NDA for long-acting testosterone drug

November 15, 2007

The FDA has accepted Indevus Pharmaceuticals’ new drug application for its long-acting depot preparation of testosterone undecanoate (Nebido) for the treatment of male hypogonadism. The NDA is predicated on data from six clinical studies in which more than 400 patients received at least one dose of the drug, more than 300 of whom were treated for more than 1 year.

The FDA has accepted Indevus Pharmaceuticals’ new drug application for its long-acting depot preparation of testosterone undecanoate (Nebido) for the treatment of male hypogonadism. The NDA is predicated on data from six clinical studies in which more than 400 patients received at least one dose of the drug, more than 300 of whom were treated for more than 1 year.

In total, more than 3,000 injections of the formulation have been given to hypogonadal males during the clinical development program, according to the company. The application includes post-marketing data from safety reporting through June 2007, reflecting the world-wide experience from more than 260,000 injections of the drug.