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U.S. Department of Health and Human Services

Drugs

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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