FDA Approves Janssen's Sporanox
- The US Food and Drug Administration has approved JanssenPharmaceutica's Sporanox (itraconozole), in oral solution form for the treatment of candidiasis of the mouth and esophagus. Clinical trials with the product demonstrated that it was as effective as the current front-line therapy, Pfizer's Diflucan (fluconazole). Of 119 patients, 86% were cured or improved after 21 days receiving 100mg of Sporanox or Diflucan per day. Gastrointestinal effects and diarrhea were the most common side effects with Sporanox, at 10.3%.
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