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Leading up to the FDA approval was a comprehensive data package demonstrating filgrastim-aafi has a high degree of similarity when compared to filgrastim.
Filgrastim-aafi is indicated by FDA label for:
- Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukaemia (AML).
- Reduction of the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.
- Chronic administration to 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.
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