The FDA has approved Axiron (testosterone topical solution, from Eli Lilly and Acrux) for replacement therapy in men ≥18yrs for conditions associated with a deficiency or absence of endogenous testosterone. Axiron is a topical, alcohol-based testosterone solution applied to the underarm once daily using a metered dose applicator allowing for no touch application. This approval was based on a Phase III multicenter, open label, 120 day clinical trial which demonstrated that 84 percent of men who completed the study achieved average serum testosterone concentration within the normal range of 300—1050 ng/dL.

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