FDA Approves Testosterone Patch at Lower Dose

Watson Pharmaceuticals, Inc., announced last month that the FDA had approved its Androderm testosterone transdermal system in reduced doses of 2 mg/day and 4mg/day, down from its original size of 2.5 mg/day and 5 mg/day. The company plans to launch the new formulation this month.

The approval of the new, lower doses was based on a trial in which 97% of subjects reached normal testosterone levels within 28 days of daily therapy. (Indeed, 94% of those taking the 4 mg/day formulation reached normal levels within eight days.) The recommended starting dose of Androderm is 4 mg/day, which can be increased to 6 mg/day or reduced to 2 mg/day depending on need.

Androderm is indicated as testosterone replacement therapy in males with a deficiency or absence of testosterone. It is a skin patch that delivers a consistent stream of the hormone through the skin for the entire day.