New Formulations of Androderm Approved

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The FDA has approved two lower-dose formulations for Androderm, a once-daily transdermal patch for men with low testosterone.

Androderm is manufactured by Watson Pharmaceuticals, Inc. in Corona, Calif., and is now available in 2 mg and 4 mg doses. The lower doses were approved after a trial showing that 94% of patients achieved normal testosterone levels after eight days of the 4 mg/day formulation, which is the recommended starting dose. Doses will then either increase to 6 mg/day or decrease to 2 mg/day depending on the needs of the patient.

According to Jed C. Kaminetsky, MD, a urologist at University Urology Associates  in New York, approximately 13.8 million men in the United States are affected by low testosterone, and its prevalence increases with age. Androderm will help treat symptoms of hypogonadism while minimizing the risk of transferring testosterone as seen in other methods such as gel preparations, he said.

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