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| |  Lamisil Tablets Cleared by FDA for Treatment of Nail Fungal Infections EAST HANOVER, N.J., May 13, 1996 -- Sandoz Pharmaceuticals Corporation announced today that it has received clearance to market LAMISIL(R) (terbinafine hydrochloride tablets) TABLETS in the United States, a major advance in the treatment of nail fungal infections (onychomycosis). The only product of its kind, the unique activity of LAMISIL leads to the death of the fungal cells that cause onychomycosis, as demonstrated by in vitro studies. The clinical relevance of these in vitro findings has not yet been established. Available in 70 countries, LAMISIL TABLETS have a global record of clinical experience. Over two million patients have been treated with LAMISIL TABLETS for nail fungus worldwide. LAMISIL TABLETS are compatible with the most commonly prescribed medications, including the widely prescribed antihistamine, Seldane(R). Unlike certain other antifungals, LAMISIL does not increase blood levels of this commonly used allergy medication which, when too high, can be lethal. One of the hardest to treat forms of external infection, onychomycosis aggressively discolors, thickens, and destroys the nail plate. An estimated 10 million individuals in the continental United States suffer from onychomycosis, an invasive infection of the nail caused by dermatophytes -- fungi like Trichophyton rubrum and Trichophyton mentagrophytes. "Until recently, onychomycosis has been very difficult to treat. Because onychomycosis is frequently hidden by the patient or overlooked by the doctor, it can develop from a condition that impedes a patient from wearing certain shoes to a full blown hot bed for painful secondary infection," commented Boni Elewski, M.D., Associate Professor of Dermatology at Case Western Reserve University, University Hospitals of Cleveland. "LAMISIL TABLETS offer the cure rates and relapse rates that make treatment of this obstinate disease both practical and convenient." People who work with their hands or on their feet, or those who are frequently exposed to detergents, perspiration, and water, are at a high risk for contracting onychomycosis. Nail fungal infections are prevalent among the elderly, athletes, military personnel, and laborers, and may be more severe in immunocompromised patients, particularly those with HIV. "LAMISIL TABLETS cleared up the infection and basically changed my life. I will be able to wear open-toed shoes, sandals, go to the beach, do all the things that people do normally and don't think twice about," remarked John Parker, a Philadelphia-area resident who was successfully treated with LAMISIL TABLETS during clinical trials. The course of treatment with LAMISIL TABLETS is 12 weeks for toenail infections and 6 weeks for fingernail infections. The drug works faster than the nail grows. Therefore, it may be several months before new clear nails grow in. LAMISIL TABLETS are available in a convenient once-a-day dosing with no dietary restrictions and can be taken with or without food. "Clinical trials show that systemic treatment with LAMISIL TABLETS is effective and safe," said Warren Joseph, D.P.M., Associate Professor of Medicine and Chief of Infectious Disease at the Pennsylvania College of Podiatric Medicine in Philadelphia. "LAMISIL TABLETS' activity against fungi, its impressive cure rates and relapse rate with short treatment time, deliver positive results. LAMISIL TABLETS are a welcome advance in our arsenal against onychomycosis." Clinical studies found that the most common side effects associated with LAMISIL TABLETS were gastrointestinal symptoms, headaches, and rash. These were generally mild and transient in nature. LAMISIL is contraindicated in individuals who are hypersensitive to terbinafine. Rare instances of symptomatic hepatobiliary dysfunction and serious skin reactions have been reported. In such cases, therapy should be discontinued. Marketed in the United States by Sandoz Pharmaceuticals Corporation, LAMISIL TABLETS will be available by prescription. Sandoz Pharmaceuticals Corporation is a leader in the discovery, development, manufacturing and marketing of innovative pharmaceuticals and high- quality consumer health products. Particular emphasis and expertise are focused on finding new treatments or cures in the areas of dermatology, oncology, neurology, and immunology. Sandoz, located in East Hanover, New Jersey, is an affiliate of Sandoz Ltd.. of Basel, Switzerland.
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