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Ortho oncology promotions

Executive Summary

Ortho's Partners in Oncology brochure, including promotional statements for Leustatin (cladribine), Duragesic CII (fentanyl transdermal system), Ergamisol (levamisole), Sporanox (itraconazole) and Nizoral (ketoconazole), lacks fair balance because it fails to present balancing risk information to its claims of efficacy, FDA says in a May 10 letter. "This violation is particularly troublesome because it went on for quite some time," the agency states. "The Form FDA 2253 indicated that the brochure was disseminated in May of 1998, yet the Form FDA 2253 was not submitted until May 25, 1999"

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