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