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FDA, MedWatch Safety Alert: Mylotarg (gemtuzumab ozogamicin): Market Withdrawal |
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Monday, 21 June 2010 00:00 |
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Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks. Any future use of Mylotarg in the United States will require submission of an investigational new drug application to the FDA.
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