Texas Biotech/GSK Argatroban "Approvable" For PCI; Dosing Data Needed
This article was originally published in Pharmaceutical Approvals Monthly
FDA is asking for further data on dosing of Texas Biotechnology/GlaxoSmithKline's argatroban before clearing the direct thrombin inhibitor for use in patients with heparin-induced thrombocytopenia (HIT) who are undergoing percutaneous coronary intervention (PCI).
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