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11/22/2002

Urokinase to Return to Market

Kate Traynor

The clot-busting enzyme urokinase (Abbokinase, Abbott), which was pulled from the market in 1999 because of serious manufacturing problems, will be reentering the market but with fewer FDA-approved indications than before.

According to the product’s new labeling, urokinase is indicated for the lysis of acute massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics. The labeling specifies use in adults, not children.

Urokinase was initially granted marketing approval in 1978. Previously approved labeling had included indications for the lysis of pulmonary and coronary artery emboli and for the clearance of occluded i.v. catheters. An Abbott spokeswoman said that the company, in its application to FDA, narrowed the product’s indication to pulmonary embolism to speed the approval process.

Abbott’s decision to withdraw its product from the market in 1999 was prompted by FDA’s discovery of major deviations from good manufacturing practices at the firm’s urokinase facility and at BioWhittaker Inc., which supplied the human kidney cells from which the enzyme is derived.

In the time that urokinase was off the market, a formulation of alteplase (Cathflo Activase, Genentech) was licensed for the restoration of function to central venous access devices.