Zarxio FDA Approval History

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

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

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)

Development timeline for Zarxio

Further information

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