Fortesta approved for testosterone deficiency

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.