Tentative FDA Approval Granted for Generic Anti-Coagulant Injection


March 30, 2010

March 30, 2010 – The FDA granted tentative approval for Teva Pharmaceutical’s abbreviated new drug application (ANDA) to market a generic version of the anti-coagulant, Argatroban injection, 100mg/mL.

The pharmaceutical is indicated as an anti-coagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia, and as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI).

The anti-coagulant effects begin immediately after infection. The drug is a synthetic direct thrombin inhibitor that does not interact with heparin anti-bodies.

On Feb. 12, a bench trial in an ongoing patent litigation with the brand drug maker GlaxoSmithKline was completed in the U.S. District Court for the Southern District of New York, opening the door for the market clearance.

The brand product had annual sales of approximately $137 million in the United States, based on IMS sales data.

For more information: www.argatroban.com, www.tevapharm.com