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No Abbokinase until Contamination Source Found|
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October 22, 2002 - Abbott Laboratories announced this month that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to reintroduce Abbokinase� (urokinase) for the treatment of pulmonary embolism. Abbokinase is a thrombolytic therapy used to dissolve blood clots. Press release from Abbott Laboratories.
Here is the Abbokinase notice on the FDA's MedWatch web site. The full, revised label is available in pdf format. July 16, 1999 - The FDA is refusing to permit Abbott Laboratories to release any more lots of Abbokinase�, a clot dissolving drug, until the source of contamination of previous lots is identified. Here is the FDA Talk Paper on the Abbokinase situation. [This message has been edited by Gary Peterson (edited 12-22-2002).] |
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renalweb.groupee.net
RenalWEB Discussion Forums
Industry News and Issues
General News
No Abbokinase until Contamination Source Found
