Bivalirudin - Eagle Pharmaceuticals

Drug Profile

Bivalirudin - Eagle Pharmaceuticals

Alternative Names: Bivalirudin RTU; EP-6101; Kangio; Ready-to-use bivalirudin; RTU bivalirudin

Latest Information Update: 23 Mar 2016

Price : $50

At a glance

  • Originator Eagle Pharmaceuticals
  • Class Antithrombotics; Hirudins; Ischaemic heart disorder therapies; Peptide fragments; Recombinant proteins
  • Mechanism of Action Thrombin inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Heparin-induced thrombocytopenia and thrombosis syndrome; Unstable angina pectoris

Most Recent Events

  • 18 Mar 2016 Eagle Pharmaceuticals receives complete response letter from the FDA for RTU bivalirudin in Heparin-induced thrombocytopenia and thrombosis syndrome and Unstable angina pectoris
  • 04 Nov 2015 Eagle Pharmaceuticals and Spectrum Pharmaceuticals agree to co-promote bivalirudin in USA for Heparin-induced thrombocytopenia and thrombosis syndrome and Unstable angina pectoris
  • 12 Aug 2015 The US FDA sets PDUFA date of 19 March 2016 for NDA review for RTU bivalirudin liquid formulation
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