GlaxoSmithKline/Texas Bio argatroban
Executive Summary
Anticoagulant argatroban receives "approvable" letter from FDA July 20 for supplemental application seeking to expand the treatment population to patients who have or who are at risk of developing thrombosis associated with heparin-induced thrombocytopenia and are undergoing percutaneous coronary intervention. Argatroban is currently approved for the prophylaxis or treatment of thrombosis in patients with HIT. The sNDA was filed in December
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