In a Perspective article in the New England Journal of Medicine the US Food and Drug Administration (FDA) offer an explanation regarding the approval Flibanserin. It opens as follows:
Was the Food and Drug Administration (FDA) approval of flibanserin (Addyi) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women long overdue? Or was it an error? In the face of divergent views, we at the FDA think it's important to clarify why flibanserin was approved after being rejected twice.
Read the full article here: http://www.nejm.org/doi/full/10.1056/NEJMp1513686#t=article
Content updated 11 December 2015