FDA Approves Novartis' Lamisil(R) Cream for Switch to OTC in the Treatment of Athlete's Foot

    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.
 
 

SOURCE  Novartis Consumer Health, Inc.