Published in Medical Letter on the CDC and FDA, August 30th, 2009
BioSante reported that with over 1,250 women enrolled and almost 825 women-years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events. This analysis of blinded data indicates a very low cardiovascular event rate has occurred thus far. Therefore, in view of the excellent LibiGel safety profile, BioSante's LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.
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