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12/17/2003

FDA Approves Sertaconazole for Athlete's Foot

Kate Traynor

Mylan Laboratories Inc. announced last week that the Food and Drug Administration (FDA) has granted marketing approval for sertaconazole nitrate topical cream, 2 percent, for the treatment of tinea pedis, better known as athlete's foot.

The fungicide will be marketed under the brand name Ertaczo, by OrthoNeutrogena, which licensed the product from Mylan in October. The product is indicated in patients 12 years or older to treat infections caused by Trichophyton rubrum, T. mentagrophyte,s and Epidermophyton floccosum.

According to the FDA-approved labeling, the infection should be confirmed, before treatment, by culture or direct microscopic examination of the skin. To treat the infection, the labeling recommends applying the cream to the affected area twice daily for four weeks. Enough product should be applied to cover the area of infection and the immediately surrounding healthy skin.

Localized skin reactions observed in clinical trials of sertaconazole included contact dermatitis, dry skin, burning, "application-site reaction," and tenderness. Adverse events reported in postmarketing studies conducted outside the United States included erythema, itching, vesiculation, desquamation, and hyperpigmentation.

Each gram of the product contains 17.5 mg of sertaconazole in a white cream base. The product is packaged in 15- and 30-g tubes for prescribing by health care providers. Tubes containing 2 g of the product will be available as physician samples.

OrthoNeutrogena has not announced when the sertaconazole cream will be available in pharmacies.