Abbott Abbokinase

Executive Summary

Reovirus was found in three lots of in-process urokinase product, FDA reports in a March 16 letter. The reovirus was detected because of testing begun this year by Abbott after FDA found production deficiencies in an inspection last fall ("The Pink Sheet" Feb. 15, p. 9). Finished lots of Abbokinase currently on the market have tested negative for reovirus in Abbott's preliminary test, but FDA noted that the test has not been validated. Additional finished lots of Abbokinase will not be available until further testing and testing validation has been completed