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news.Indevus Pharmaceuticals has reported that that FDA has accepted for review its new drug application for Nebido, a long-acting injectable testosterone preparation for the treatment of male hypogonadism.
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The new drug application (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 Nebido 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 Nebido.
The FDA prescription drug user fee act target action date for Nebido is June 27, 2008. The NDA was submitted by the company on August 28, 2007.