The FDA has approved Androderm (testosterone transdermal system; Watson) in 2mg and 4mg formulations. The smaller-sized and lower-dose patch reflects a 20% reduction in the active ingredient from the original strength. The approval of the lower dose formulation was based on study data showing that 97% of patients achieved testosterone concentrations within the normal range after 28 days of daily therapy. In the study, 94% of patients achieved normal testosterone levels by Day 8 with the 4mg formulation.

Androderm is indicated as testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Androderm 2mg and 4mg are expected to be made available in November 2011.

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