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Testosterone Gel Earns FDA Approval

Kate Traynor

Auxilium Pharmaceuticals Inc. of Norristown, Pa., announced last Friday that the Food and Drug Administration (FDA) has approved the marketing of Testim, the company's testosterone-replacement-therapy gel.

According to the product's labeling, Testim is indicated for testosterone replacement therapy in adult men with primary or hypogonadotropic hypogonadism. The product is contraindicated in women and in men with cancer of the breast or prostate.

Testim, which will be marketed early next year, is formulated as a hydroalcoholic topical gel containing 1 percent testosterone, a Schedule III controlled substance. The product will be supplied to pharmacies in 5-g tubes, each containing 50 mg of testosterone and 5 g of gel, packaged in cartons of 30 tubes. The gel contains cyclopentadecanolide, a drug-delivery enhancement agent produced by Bentley Pharmaceuticals Inc. of North Hampton, N.H.

The recommended daily dose is one tube, preferably administered in the morning. When applied to the clean, dry, intact skin of the shoulders or upper arms, the product provides continuous delivery of testosterone for 24 hours. Testim should not be applied to the skin of the abdomen or genitals.

According to the product's labeling, men should have their morning serum testosterone concentration measured 14 days after starting therapy to ensure that a proper systemic level of the hormone is achieved. If the response is inadequate, the dosage can be doubled with a physician's recommendation.

Patients are cautioned to cover the application sites to avoid transferring the drug to other people by skin contact. If skin contact is likely to occur, the labeling states that the patient should wash the application site with soap and water. To remain effective, the product must remain in place for at least two hours before washing.