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| |  FDA Approves Lamisil For Switch To OTC In Athlete's Foot Treatment SUMMIT, NJ -- March 11, 1999 -- The United States Food and Drug Administration has approved a switch of Novartis Consumer Health’s Lamisil(R) Cream, 1% (terbinafine HCl cream) from prescription drug status to over-the-counter (OTC) status for the treatment of athlete's foot. Lamisil(R)AT(TM) Cream is the only OTC medication that cures athlete's foot with just one week of treatment. FDA approval of LamisilAT is a significant event in the antifungal category as it marks the first prescription-to-OTC switch for athlete's foot in nearly a decade. Prescription Lamisil is the number one product prescribed for athlete's foot. LamisilAT contains prescription-strength terbinafine, which has been shown to kill athlete's foot fungus in laboratory tests. As the medication most prescribed for athlete's foot, prescription Lamisil has been used by millions of people and has an excellent safety profile. "Until now, physicians shared our patients' frustration with athlete's foot. Instead of continuing treatment for the full four-week time period, many patients would stop using the treatment once their symptoms were relieved, often leading to a recurrence of the condition," said Nardo Zaias, M.D., acting director, dermatology, Mount Sinai Hospital, Miami Beach, FL. "Since LamisilAT cures with just one week of treatment, as compared to four weeks of treatment, I am confident that patients and physicians alike will benefit greatly from this new, faster treatment option." Athlete's foot or tinea pedis is a skin fungal infection of the foot affecting more than 10 percent of the U.S. population each year. In interdigital-type athlete's foot, the skin between the third, fourth and fifth toes forms blisters and can become white, moist and easily rubbed off. Sometimes there is a red, dry, flaky quality to the skin. Moccasin-type athlete's foot is characterised by many of the same signs, but occurs on the sides or bottom of the foot. LamisilAT is indicated for both types of athlete's foot. This occurs most often in hot, moist weather or if shoes are worn often, limiting exposure to air. The chief symptoms of athlete's foot are itching and burning. A large percentage of sufferers are men between the ages of 25-54, but many women suffer as well. Activities that increase the risk of contracting athlete's foot include walking barefoot on infected floors such as public bathrooms, swimming pools or locker rooms and on rugs, mats or showers shared with infected family members. Improper hygiene, prolonged moist skin and minor skin or nail injuries increase susceptibility. Lamisil tablets is the leading prescription remedy for the treatment of nail fungal disease (onychomycosis) and will remain available only by prescription.
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