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Difficulties in Obtaining Sufficient Amounts of Urokinase (Abbokinase®)
The Food and Drug Administration (FDA) has received inquiries about difficulties in obtaining sufficient amounts of Abbokinase® (Urokinase), a thrombolytic agent manufactured by Abbott Laboratories. FDA approved indications for Abbokinase® are: pulmonary embolism, coronary artery thrombosis, and I.V. catheter clearance. On December 9, 1998, Abbott Laboratories issued a letter to customers indicating Abbott's temporary inability to ship Abbokinase® to its customers.
FDA's Center for Biologics Evaluation and Research (CBER) evaluates lot release protocols for each lot of Urokinase prior to its release to the public. This lot release mechanism is one of the methods used by FDA to ensure that biological products are safe and have been manufactured in accordance with laws and regulations.
During inspections of Abbott, FDA observed significant deviations from Current Good Manufacturing Practices. Until our review of the inspectional findings and information recently submitted by Abbott is complete, CBER will not release any of this product.
It is the Agency's view that alternative products are available. Other thrombolytic products on the US market with well-described experience in multiple indications include Streptase®, Kabikinase® (Streptokinase), Activase® (Alteplase/tPA), Eminase® (Anistreplase), and Retavase® (Reteplase). We encourage all physicians to consider the appropriateness of other treatment options. The following is a list of FDA-approved indications for each of the thrombolytic products currently available in the US:
Streptase® (Hoechst Marion Roussel)-distributed by Astra USA
Acute evolving transmural myocardial infarction
Pulmonary embolism
Deep vein thrombosis
Arterial thrombosis or embolism
Occlusion of arteriovenous cannulae
Kabikinase® (Pharmacia & Upjohn AB)
Acute evolving transmural myocardial infarction
Pulmonary embolism
Deep vein thrombosis
Arterial thrombosis or embolism
Activase® (Genentech, Inc.)
Acute myocardial infarction
Acute ischemic stroke
Pulmonary embolism
Eminase® (Wulfing Pharma GmbH)-distributed by Roberts Pharmaceutical Corporation
Acute myocardial infarction
Retavase® (Centocor, Inc.)
Acute myocardial infarction
Date: 12/11/98
Last Updated: 1/10/2001
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Updated: September 26, 2003 |
