Medicis Pharmaceutical Corp.

New York, NY: (May-08-07) The US Department of Justice filed charges against Medicis Pharmaceutical Corp., alleging that it promoted its anti-fungal cream Loprox for unapproved uses. The suit claimed that the drug company had allegedly promoted Loprox, a medication typically used for fungal skin conditions such as athlete's foot, among pediatricians as a treatment for diaper rash from about November 2001 through April 2004. The US Food and Drug Administration had only approved Loprox, known chemically as ciclopirox, as a fungicide for patients over 10 years of age. In a settlement reached, Medicis Pharmaceutical agreed to pay the Department of Justice $9.8 million to settle allegations. It did not admit any liability in agreeing to the monetary settlement. Medicis Pharmaceutical has also agreed to enter into a Corporate Integrity Agreement with the Department of Health and Human Services in an effort to show that it was reinforcing regulatory compliance in the sale and promotion of its products. [REUTERS: OFF-LABEL LOPROX]

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Published on May-10-07