The U.S. Food and Drug Administration has accepted Indevus Pharmaceuticals Inc.'s (NASDAQ:IDEV) New Drug Application (NDA) for Nebido. The NDA was submitted August 28, 2007 and the target action date for the drug is June 27, 2008.
Nebido is a long-acting testosterone injection for the treatment of hypogonadism. The NDA contained data from six clinical trials of over 3,000 injections as well as data from 260,000 injections worldwide.
Hypogonadism is a medical condition in which there is an absence or reduction of testosterone in the testes. Reduced testosterone levels can lead to decreased sexual desire, muscle loss and weakness and the increased risk of osteoporosis. It is estimated that four to five million men in the U.S. suffer from hypogonadism and less than 10% are receiving treatment with testosterone therapy.
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