Endo Pharmaceuticals announced that the FDA has approved Fortesta (testosterone gel) for the treatment of hypogonadism, also referred to as low testosterone (Low T) in men ≥18yrs. Fortesta is a clear, odorless gel in a metered-dose pump that delivers the correct dose per complete depression to be applied gently with one finger to the front and inner thighs.  This approval was based on results from a 90-day multicenter, open-label, non-comparative Phase 3 study that showed 78% of men with hypogonadism using Fortesta gel had an average serum total testosterone concentration within the normal range at day 90.

Fortesta is a C-III controlled substance. Fortesta gel is expected to be made available by Endo Pharmaceuticals in early 2011.

For more information call (800) 462-ENDO or visit www.endo.com.