FDA greenlights Teva's generic anticoagulant

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The FDA has tentatively given Teva Pharmaceuticals a nod of approval for its abbreviated new drug application to market the generic version of the anticoagulant injection Argatroban (GlaxoSmithKline) in 100 mg/mL doses.

The drug is indicated for prophylaxis treatment of thrombosis in heparin-induced thrombocytopenia patients, according to Teva. The Jerusalem-based company said the branded product reaps an annual profit of $137 million, based on data from IMS Health.