NEUPOGEN
Neupogen (filgrastim) is a leukocyte growth factor used to manage neutropenia and reduce the risk of infection in various clinical settings. It is primarily indicated for patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy or undergoing bone marrow transplantation, as well as those with acute myeloid leukemia. Additionally, the drug is used to mobilize progenitor cells for collection and to treat patients with chronic hereditary neutropenia or acute exposure to myelosuppressive radiation.
How NEUPOGEN Works
Filgrastim acts as a colony-stimulating factor by binding to specific receptors on the surface of hematopoietic cells. This binding stimulates the production, maturation, and activation of neutrophils within the bone marrow. By regulating neutrophil progenitor proliferation and enhancing functions like phagocytosis, the drug increases the body's ability to fight infections while having minimal impact on other blood cell types.
Details
- Status
- Prescription
- First Approved
- 1991-02-20
- Routes
- N/A
- Dosage Forms
- SYRINGE, VIAL
NEUPOGEN Approval History
What NEUPOGEN Treats
7 indicationsNEUPOGEN is approved for 7 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Myeloid Leukemia
- Neutropenia
- Hematopoietic Syndrome of Acute Radiation Syndrome
- Congenital Neutropenia
- Cyclic Neutropenia
- Idiopathic Neutropenia
NEUPOGEN Biosimilars
4 FDA-approvedThese 4 alternatives require prescriber approval to substitute for NEUPOGEN.
What are biosimilars? Lower-cost alternatives to NEUPOGEN with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEUPOGEN FDA Label Details
ProIndications & Usage
FDA Label (PDF)NEUPOGEN 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 malignanci...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.