US FDA accepts BioSante, Teva application for hypogonadism drug
This article was originally published in Scrip
Executive Summary
The US FDA has accepted for review the new drug application for BioSante's and Teva's testosterone gel Bio-T-Gel as a treatment for male hypogonadism or low testosterone levels, which results from a signaling problem between the brain and the testes, causing levels of the hormone to drop below normal.