Lamisil gets FDA OK for athlete's foot switch

Drug Store News, April 26, 1999

SUMMIT, N.J. -- Novartis Consumer Health has received Food and Drug Administration approval to switch its Lamisil Cream for the treatment of athlete's foot from prescription to OTC status.

Lamisil's active ingredient is terbinafine in a 1 percent strength--a strength it will carry into OTC status. After the switch, Lamisil Cream will be the only OTC medication that cures athlete's foot in one week, according to the company; other OTC products require a four-week regimen. "Until now, physicians shared our patients' frustration with athlete's foot," said Nardo Saias, M.D., acting director, dermatology, Mount Sinai hospital, Miami Beach, Fla. "Instead of continuing treatment for the full four-week time period, many patients would stop using the treatment once symptoms were relieved, often leading to a recurrence of the condition."

The Rx-to-OTC switch is also significant in the antifungal category since it marks the only switch in the athlete's foot category in nearly a decade. Novartis also markets Lamisil tablets, a prescription treatment for nail fungal disease.