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FDA approves new formulation of Watson's Androderm

Transdermal patch used for treating hypogonadism in men

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of its Androderm (testosterone) transdermal system in the 2-mg and 4-mg formulation. The company said the new smaller size and lower-dose patch would provide "highly effective" testosterone administration with a 20% reduction in the active ingredient from the original strength. Watson plans to launch the new patch next month.

The drug is a testosterone replacement therapy used to treat deficiency or absence of the hormone produced by the body, a condition that affects some 13.8 million men and results from such causes as genetic abnormalities, side effects of some medications, diabetes and injury to the testes.

"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 under-diagnosed and under-treated condition," New York University School of Medicine and University Urology Associates urologist Jed Kaminetsky said on behalf of Watson. "The new Androderm formulation effectively treats symptoms of male hypogonadism, which include decreased sexual desire, fatigue and mood depression."


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