Watson Pharmaceuticals Inc. has received approval from the Food and Drug Administration for 2-mg and 4-mg formulations of its Androderm testosterone transdermal system.


Watson Pharmaceuticals, Androderm, lower-dose testosterone patch, testosterone transdermal system, testosterone patch, new Androderm formulation, low testosterone, Jed Kaminetsky








































































































































































































































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Watson to market lower-dose testosterone patch

October 21st, 2011

PARSIPPANY, N.J. – Watson Pharmaceuticals Inc. has received approval from the Food and Drug Administration for 2-mg and 4-mg formulations of its Androderm testosterone transdermal system.

The company said Friday that the new, lower-dose testosterone patch provides highly effective testosterone administration with a 20% reduction in the active ingredient from the original strength in a smaller patch size.

Plans call for Watson to launch the new Androderm formulation next month. The product will be marketed in the U.S. by the company's Global Brands business.

Androderm — applied to the back, abdomen, thighs or upper arms — is indicated as testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone. Low testosterone affects an estimated 13.8 million men in the United States, and its prevalence increases with age, according to Watson.

"The approval of the new low-dose testosterone patch offers millions of men a reliable and convenient transdermal option for what continues to be an underdiagnosed and undertreated condition," stated Dr. Jed Kaminetsky, a urologist at University Urology Associates and clinical assistant professor of urology at the New York University School of Medicine. "The new Androderm formulation effectively treats symptoms of male hypogonadism, which include decreased sexual desire, fatigue and mood depression. In addition, the patch helps minimize the risk that the testosterone may be transferred from patients to children or women, unlike testosterone gel preparations."

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