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FDA Approves Cathflo Activase

Genetech, Inc. announced in September that its thrombolytic agent Cathflo Activase (alteplase, recombinant) has been approved by the US Food and Drug Administration for restoration of function to central venous access devices (CVADs), as assessed by the ability to withdraw blood. Cathflo Activase is available in a 2-mg single-patient-use vial. The approval of Cathflo Activase addresses the medical community's need for a safe and effective treatment to open occluded CVADs. Cathflo Activase is a recombinant form of a naturally occurring enzyme produced by the body known as tissue plasminogen activator. It is a thrombolytic agent that works by targeting fibrin (the substance that causes blood to clot) to dissolve the clot.


In the phase III COOL (Cardiovascular Thrombolytic to Open Occluded Lines) trials, Cathflo Activase was found to be approximately 88% effective in restoring flow to catheter lines. Excessive pressure should be avoided when Cathflo Activase is instilled. Such force could cause rupture of the catheter or expulsion of the clot into circulation.


In September 2000, Genetech, Inc., filed a Supplemental Biologic Licensing Application (sBLA) with the US FDA for Cathflo Activase. There are currently no other pharmaceutical agents available for this indication. Cathflo Activase is marketed in a different dosing regimen under the trade name Activase for the treatment of acute myocardial infarction, acute ischemic stroke within 3 hours of symptom onset, and acute massive pulmonary embolism. For more information call (908) 234-9626 or visit


Carnitor Injection Is Available in Easy-to-use Vial

Carnitor (levocarnitine) Injection, manufactured by Sigma Tau Pharmaceuticals, is available in a convenient, easy-to-use 5 mL vial, 200 mg/mL. Carnitor Injection is the only levocarnitine replacement therapy approved by the US Food and Drug Administration for the prevention and treatment of cartinine deficiency in patients with end-stage renal disease (ESRD) who are undergoing dialysis. FIGURE

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Carnitor Injection has been demonstrated to increase serum carnitine concentrations in ESRD patients to the therapeutic ranges established as being efficacious. Adverse events reported with Carnitor include nausea, vomiting, body odor, gastritis, and seizures. There are no reported contraindications or warnings. Only the intravenous form of levocarnitine is indicated for use in ESRD patients on hemodialysis. For more information about Carnitor Injection call (800) 447-0169 or visit