Bendamustine - Eagle Pharmaceuticals

Drug Profile

Bendamustine - Eagle Pharmaceuticals

Alternative Names: Bendamustine 500mL; Bendamustine 50mL; Bendamustine II; Bendamustine rapid infusion; Bendamustine RI; Bendamustine RTD; Bendamustine shorter-infusion; Bendeka; EP-3101; EP-3102; RTD bendamustine

Latest Information Update: 28 Jul 2018

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At a glance

  • Originator Eagle Pharmaceuticals
  • Class Antineoplastics; Benzimidazoles; Butyric acids; Nitrogen mustard compounds; Nitrosourea compounds; Small molecules
  • Mechanism of Action Alkylating agents; Antimetabolites; DNA cross linking agents
  • Orphan Drug Status

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

    Yes - Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma
  • No development reported Solid tumours

Most Recent Events

  • 28 Jul 2018 No recent reports of development identified for phase-I development in Solid-tumours(Recurrent, Second-line therapy or greater) in USA (IV, Infusion)
  • 09 Jul 2018 The US FDA grants seven years of orphan drug exclusivity for bendamustine (low-volume [50 mL] and short-time 10-minute infusion formulation) in USA for Chronic lymphocytic leukaemia and Non-Hodgkin's lymphoma
  • 03 Jul 2018 Eagle Pharmaceuticals has patent protection for Bendamustine in USA
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