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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
April 9, 2009

Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA


FDA Approves Benzyl Alcohol Lotion for the Treatment of Head Lice

The U.S. Food and Drug Administration today approved a new prescription medication for the treatment of head lice (Pediculosis capitis) infestation. Benzyl Alcohol Lotion, 5%, received full market approval as a prescription medication, for use in patients 6 months of age and older.

Benzyl Alcohol Lotion, 5%, is the first head lice product approved by the FDA with benzyl alcohol as the active pharmaceutical ingredient.

"Head lice are a problem that impacts more than a 1 million children each year and is easily transmitted to others," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research. "This drug is an effective first line treatment to eliminate lice infestation, and minimize disruption in the daily routines of families."

The safety and effectiveness of Benzyl Alcohol Lotion, 5%, was demonstrated in two studies of 628 people, 6 months of age and older, with active head lice infestation. The subjects received two, 10-minute treatments of either Benzyl Alcohol Lotion or a topical placebo, one week apart. Fourteen days after the final treatment, more than 75 percent of the subjects treated with Benzyl Alcohol Lotion, 5%, were lice free.

Common side effects of the medication include irritations of the skin, scalp, and eyes, and numbness at the site of application. As with all medications, it is important to use benzyl alcohol, 5%, as labeled to maximize benefits and minimize risks. The product should be applied only to the scalp or the hair attached to the scalp. It is not approved for use in children younger than six months. Use in premature infants could lead to serious respiratory, heart- or brain-related adverse events such as seizure, coma, or death.

Benzyl Alcohol Lotion, 5%, is distributed by Sciele Pharma Inc., a subsidiary of Atlanta-based Shionogi Company.

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