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FDA approves Zovirax Cream for cold sore treatment

TORONTO, CANADA, Jan. 3, 2003 -- Biovail Corporation announced that it has received approval from the FDA for Zovirax (acyclovir) Cream, a topical medication used for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents 12 years of age and older.

Cold sores are the result of a virus, which causes painful lesions that range from mere redness, to pimple-like sores, to blisters. It is estimated that 20-40 percent of the U.S. adult population has had a cold sore at some point.

Market research shows that, when asked to choose among products applied directly to the sore, many patients prefer a cream-based topical medication to ointments when treating cold sores. Zovirax Cream is not a cure for cold sores.

In studies, the most common skin-related side effects with Zovirax Cream were local application site reactions, occurring in five percent of patients. These reactions included dry or cracked lips, flakiness or dryness of skin, a burning or stinging feeling or itching of the skin. Each event occurred in fewer than one percent of patients.

Biovail acquired the exclusive rights for U.S. promotion and distribution of Zovirax Cream from GlaxoSmithKline (GSK) in the fourth quarter of 2001, with an effective date of January 1, 2002. Biovail intends to launch Zovirax Cream in 2003.

Source: Biovail

Posted: January 2003