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Unimed AndroGel

Executive Summary

Testosterone replacement gel approved Feb. 28 for males with a "deficiency or absence of endogenous hormone" including primary hypogonadism and hypogonadotropic hypogonadism. The 5 g, 7.5 g or 10 g dose delivers 50 mg, 75 mg and 100 mg of testosterone and is applied daily to the dry skin of the shoulders, upper arms or abdomen. As a Phase IV commitment, the company must show that there is no difference in the clinical delivery of the marketed drug as compared to the clinical trial formulation
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