Advertisement Watson testosterone transdermal delivery system wins FDA approval - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Watson testosterone transdermal delivery system wins FDA approval

The US Food and Drug Administration (FDA) has approved Watson Pharmaceuticals' Androderm (testosterone transdermal system) 2 mg and 4 mg formulation, which is likely to be launched in November 2011.

Androderm,a once daily skin patch, called a transdermal delivery system, is a testosterone replacement therapy in males with a deficiency or absence of endogenous testosterone. It delivers consistent, controlled concentrations of testosterone through the skin.

The new testosterone patch which comes in smaller size and lower-dose provides 20% reduction in the active ingredient from the original strength in a smaller patch size.

The approval occured following a trial that demonstrated 97% of the subjects achieved testosterone concentrations within the normal range after 28 days of daily therapy.