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Genentech Cathflo Activase is approved

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA clears tissue plasminogen activator alteplase Sept. 4 for restoring function to occluded central venous access catheters. Genentech's Cathflo Activase will be sold in 2 mg single-use vials, while Activase, indicated for acute MI, acute ischemic stroke and acute massive pulmonary embolism, is sold in 50 and 100 mg vials (Pharmaceutical Approvals Monthly, February 2001, p. 18). The only other product approved for clearing occluded catheters is Abbott's Abbokinase (urokinase), which was pulled from the market in 1999 for GMP deficiencies. Abbott anticipates re-launching its drug in first quarter 2002

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