NDA for expected to be filed in 2010; Phase III trials in progress 7/08; expected FDA review by 2011 8/09; independent data review by the DMC independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review of unblinded data recommended continuation of the study as described in the study protocol, with no modifications (10/09); DMC recommends continuation of phase III study with estimated NDA submission in mid-2011 (2/10); positive phase III safety data reported 6/10; new 6mo randomized trial evaluating effect on cognitive function in menopausal women (7/10)
Brand LibiGel Generic testosterone
Company name BioSante Product type Non-speciality
Therapeutic category Endocrine and Diabetes Key uses Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women
Other Uses N/A Drug Class gel formulation of testosterone
Dosage From topical gel Expected Approval 2012+
FDA Filing N/A Last Update date July 14,2010
Link to pipeline report
Link to news article
Link to clinicaltrials.gov
Link to press releases