SUSPENSION OF MANUFACTURE, IMPORTATION, DISTRIBUTION, AND/OR MARKETING OF KETOCONAZOLE ORAL PRODUCTS
The Food and Drug Administration is informing all concerned of its decision to suspend the marketing authorizations of oral ketoconazole - containing products effective immediately. The decision was finalized after deliberation on the negative risk-benefit assessment for ketoconazole - containing products. It was concluded that risk of serious liver injury outweighs the benefits in treating fungal infections.
Accordingly, all concerned establishments are hereby ordered to immediately cease and desist from further manufacturing, importing, distributing, selling or offer for sale of oral ketoconazole products. Evaluation of applications for registration covering oral ketoconazole products, as well as approval of those already evaluated, are likewise suspended. Doctors should discontinue prescribing oral ketoconazole products and recommend an appropriate alternative for fungal infections. Patients currently on oral ketoconazole should consult their doctor for alternative treatment.
Download the Attachment to continue reading.