FDA Approves Novartis' Lamisil(R) Cream for Switch to OTC in the Treatment of Athlete's Foot
First and Only OTC Medication to Cure Athlete's Foot with
Just One Week of Treatment
SUMMIT, N.J., March 11 /PRNewswire/ -- Novartis Consumer Health announced today that the U.S. Food and Drug Administration (FDA) has given Novartis approval to switch 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 is the most exciting news in the OTC antifungal athlete's foot category in more than 50 years. Until now, no new OTC therapy has provided such a significant reduction in treatment time. LamisilAT provides a whole new mechanism of action that cuts treatment time by 75 percent versus anything on store shelves," said Fred Huser, President and CEO, Novartis OTC. 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, Fla. "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 characterized 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. Novartis Consumer Health, headquartered in Summit, New Jersey, is a leading consumer pharmaceuticals and foods company. The Division includes Gerber Products Company, Novartis OTC (over-the-counter medicines) and Medical Nutrition. Focusing on consumer needs and preferences, each NCH Sector provides well-known, high-quality products to enhance overall health and well-being for millions of American consumers each day. Novartis is a world leader in Life Sciences with core businesses in Healthcare, Agribusiness and Consumer Health (Self-Medication and Nutrition). In 1998, Novartis Group sales were 31.7 billion Swiss francs, of which 17.5 billion were in Healthcare, 8.4 billion in Agribusiness and 5.8 billion in Consumer Health. The group annually invests more than 3.6 billion Swiss francs in R&D. Headquartered in Basel, Switzerland, Novartis employs about 85,000 people and operates in over 100 countries around the world. For more information, contact Elise Liebman of GCI Healthcare, 212-886-3062 for Novartis or Kate King of Novartis Consumer Health, 908-598-7039.RELATED LINKS
SOURCE Novartis Consumer Health, Inc.