FDA Approves Lamisil(R)(AT)(TM) Solution for Switch to OTC
Novartis Consumer Health Speeds to Market with Fastest Consecutive Rx-to-OTC
Switch Under the Lamisil AT Brand Name
SUMMIT, N.J., March 21 /PRNewswire/ -- Novartis Consumer Health, Inc. announced today that the U.S. Food and Drug Administration (FDA) has given approval to switch Lamisil(R) Solution, 1% (terbinafine HCl solution), from prescription to over-the-counter (OTC) status for the treatment of interdigital athlete's foot, jock itch and ringworm. Lamisil(R)(AT)(TM) Spray Pump and Lamisil(R)(AT)(TM) Solution Dropper are the only OTC antifungal liquids that cure athlete's foot between the toes with just one-week of treatment. The new liquid products will be introduced in the spring of 2000, just in time for the peak summer athlete's foot season. The approval of Lamisil(AT) Spray Pump and Lamisil(AT) Solution Dropper follows the switch of Lamisil(AT) Cream within just twelve months. This may well be the fastest consecutive switch under a single brand name in the history of prescription to over-the-counter switches. Lamisil(AT) Cream was granted switch approval March 9, 1999. Lamisil(AT) Cream achieved the number one market share just five weeks after launch and OTC unit sales surpassed prescription unit sales in just 15 weeks. Lamisil(AT) Spray Pump and Lamisil(AT) Solution Dropper are also expected to be market leaders, since they contain the same full-prescription strength medicine as Lamisil(AT) Cream. "Patients are 'form loyal' in the athlete's foot category," said Nardo Zaias, MD, Director, Dermatology at Mount Sinai Medical Center, Miami Beach, Fl. "Lamisil(AT) Spray Pump and Lamisil(AT) Solution Dropper offer more delivery options while providing a superior dosing regimen of one week of treatment for athlete's foot between the toes versus four weeks for all other OTC liquid antifungal products." Lamisil(R) Tablets is the leading prescription oral antifungal for the treatment of fungal nail infection (onychomycosis) and will remain available only by prescription. Lamisil(R) Solution, 1%, will also remain available by prescription-only for the topical treatment of tinea versicolor. Lamisil(AT) is marketed by Novartis Consumer Health, Inc. Novartis Consumer Health, headquartered in Summit, New Jersey, manufactures, develops and markets a wide range of branded products the purpose of which is to restore, maintain or improve consumer health. Key businesses include OTC (over-the-counter medicines), Health and Functional Nutrition, Baby and Infant Business, Vitamins/Minerals/Supplements and Ingredients and Medical Nutrition products. Novartis is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of USD 21.7 billion and invested more than USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000. Contact: Kate King of Novartis Consumer Health, 908-598-7039RELATED LINKS
SOURCE Novartis Consumer Health, Inc.