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, 908-598-7039
SOURCE Novartis Consumer Health, Inc.
RELATED LINKShttp://www.us.novartis.com
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