Urokinase to Return to Market
According to the products 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 products indication to pulmonary embolism to speed the approval process.
Abbotts decision to withdraw its product from the market in 1999 was prompted by FDAs discovery of major deviations from good manufacturing practices at the firms 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.