Balugrastim

Drug Profile

Balugrastim

Alternative Names: Albugranin; Albumin fused G-CSF; CG-10639; Egranli; G-CSF/albumin human - Teva; Long-acting Granulocyte Colony Stimulating Factor (G-CSF) - Teva; Neugranin; Pegfilgrastim biosimilar - Teva

Latest Information Update: 13 Aug 2015

Price : $50

At a glance

  • Originator CoGenesys
  • Developer Teva Pharmaceutical Industries
  • Class Chemoprotectants; Granulocyte colony-stimulating factors
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Submission Withdrawal Neutropenia

Most Recent Events

  • 01 Jan 2015 Teva terminates phase II trial in Neutropenia (Chemotherapy-induced, In children, In adolscents) in USA, Bulgaria, Hungary, Romania, Russia, Ukraine, Poland, Georgia, Czech Republic and Slovakia (NCT01940601) prior to enrolment initiation
  • 04 Nov 2014 Regulatory submission withdrawn for Neutropenia (Chemotherapy-induced) in European Union (SC)
  • 26 Sep 2014 Preregistration for Neutropenia (Chemotherapy-induced) in European Union before September 2014 (SC)
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