bivalirudin

FDA Drug Profile — Bivalirudin, bivalirudin

Drug Details

Generic Name
bivalirudin
Brand Names
Bivalirudin, bivalirudin
Application Number
ANDA210031
Sponsor
Ambiopharm, Inc.
NDC Codes
8
Dosage Forms
POWDER, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
BIVALIRUDIN

Indications and Usage

1 INDICATIONS AND USAGE Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). ( 1 )