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Gemtuzumab Ozogamicin Injection

[19 October 2010]

Products Affected - Description

Mylotarg, Pfizer
5 mg vial, lyophilized powder for injection (NDC 00008-4510-01)

Reason for the Shortage

Pfizer is withdrawing Mylotarg from the market because the post-approval study did not show survival benefit and increased toxicity was seen over standard chemotherapy for patients with acute myeloid leukemia.

Estimated Resupply Dates

Pfizer has withdrawn Mylotarg from the US market. No new patients should be started on Mylotarg at this time. Patients currently on Mylotarg should consult their healthcare professional and may continue therapy if clinically appropriate.

Related Shortages

Updated

October 19, 2010, University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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In Cooperation With

University of Utah & Novation
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