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www.fdanews.com/articles/63454-novartis-anti-itch-eyedrops-approved-for-otc-sale

NOVARTIS' ANTI-ITCH EYEDROPS APPROVED FOR OTC SALE

October 23, 2006

Novartis Pharmaceuticals announced that the FDA has approved prescription Zaditor (ketotifen fumarate ophthalmic solution 0.025 percent), indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, for OTC use. An estimated 40 million Americans suffer from eye allergies.

While most OTC products provide only three to four hours of relief, Zaditor's full prescription-strength formula offers eye itch relief that works in minutes and lasts up to 12 hours with just one drop. In addition, Zaditor is the first OTC eye itch medication safe for use in children as young as 3.

Zaditor is the only OTC drop to treat eye itch associated with pollen, ragweed, grass, animal hair and dander without the potentially negative effects of a decongestant. Many OTC eye drops contain topical decongestants, which constrict the blood vessels to reduce the appearance of redness in the eye. With regular use, these products can interfere with the eye's natural ability to regulate the blood vessels, resulting in a continued redness for a period of time after discontinuation (rebound effect). Zaditor does not contain a decongestant and may be used without risk of rebound redness.

Approved in 1999 for prescription use, Zaditor has become a leading treatment for the temporary prevention of itchy eyes due to allergic conjunctivitis. Zaditor will be available OTC in drug and chain stores nationwide in January 2007. It has a suggested retail price of $14.99 for a 30-day supply. In clinical studies, Zaditor was well-tolerated and any side effects are generally mild.