Zarxio FDA Approval History

FDA Approved: Yes (First approved March 6, 2015)
Brand name: Zarxio
Generic name: filgrastim-sndz
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia, Neutropenia Associated with Radiation, Bone Marrow Transplantation, Peripheral Progenitor Cell Transplantation, Hematopoietic Syndrome of Acute Radiation Syndrome

Last updated by Judith Stewart, BPharm on April 1, 2025.

Zarxio (filgrastim-sndz) is a leukocyte growth factor biosimilar to Neupogen (filgrastim).

• Zarxio is a leukocyte growth factor indicated to:
  - Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever
  - Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
  - Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)
  - Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
  - Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia
  - Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)

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Development timeline for Zarxio

Further information

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