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Releuko FDA Approval History

Last updated by Judith Stewart, BPharm on March 16, 2022.

FDA Approved: Yes (First approved February 25, 2022)
Brand name: Releuko
Generic name: filgrastim-ayow
Dosage form: Injection
Company: Amneal Pharmaceuticals LLC
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia

Releuko (filgrastim-ayow) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.

  • Releuko is 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).
    • 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.
  • Releuko is administered via subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.

Development timeline for Releuko

Mar  2, 2022Approval FDA Approves Releuko (filgrastim-ayow), a Biosimilar to Neupogen

Further information

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