Lowers the risk of mortality. Sold as Nulibry. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Fosdenopterin Hydrobromide (sold as Nulibry), first approved Feb 26, 2021, with 1 new use approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 26, 2021 | NulibryNDA 214018 · New molecular entity | Sentynl Theraps Inc | 2 | Marketed |
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
