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1/2/2003

FDA Approves Rosacea Treatment

Kate Traynor

Berlex Laboratories Inc. announced today that the Food and Drug Administration (FDA) approved the marketing of Finacea gel, containing 15 percent azelaic acid, for the treatment of rosacea.

Finacea is indicated for the topical treatment of the inflammatory papules and pustules associated with mild to moderate rosacea.

According to Berlex, its 15 percent azelaic acid gel is the first new product in more than 10 years with FDA-approved labeling for the treatment of rosacea, a disease that affects more than 13 million adults in the United States.

Berlex said it expects to have the product available by the end of March.

According to the company, itching, burning, and tingling have occurred in more than 10 percent of azelaic acid gel users, and dry skin and rash have affected up to 10 percent of users. Finacea contains propylene glycol and is contraindicated in people who are allergic to this substance.

Full prescribing information for Finacea is available from Berlex at 888-237-5394.