Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats acute myeloid leukemia (AML). Sold as Nivestym. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Filgrastim-Aafi (sold as Nivestym), first approved Jul 20, 2018, with 0 new uses approved and 0 published complete response letters.
First approved: Jul 20, 2018
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $23.3M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
GranDrugs with a new indication and a new dosage for use as an adjunctive therapy with antineoplastic agents for the treatment of relapsed or refractory acute… · Kyowa Kirin Co., Ltd. · Jun 20, 2022
GranDrugs with a new indication and a new dosage for the enhancement of an antitumor effect of dinutuximab (genetical recombination) for neuroblastoma. · Kyowa Kirin Co., Ltd. · Jun 23, 2021
Clinical Trials
20 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
