For non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with…. Sold as Rolvedon. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Eflapegrastim-Xnst (sold as Rolvedon), first approved Sep 9, 2022, with 0 new uses approved and 1 published complete response letter.
| Rolvedon | Part B | $72.3M | -2% | 7,175 |
| Rolvedon | Part D | $2.9M | +80% | 191 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Sep 9, 2022 | RolvedonBLA 761148 · New molecular entity | Spectrum Pharms | 2 | Marketed |
| Letter | Product | Now |
|---|---|---|
| Aug 3, 2021 | SPI-2012Product Quality | Approved |
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
