Treats chronic hepatitis C virus (HCV). Sold as Harvoni. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 2 applications for Ledipasvir; Sofosbuvir (sold as Harvoni), first approved Oct 10, 2014, with 12 new uses approved and 0 published complete response letters.
| Harvoni | Part D | $13.5M | -62% | 183 |
| Ledipasvir-Sofosbuvir | Part D | $5.2M | +80% | 184 |
| Oct 10, 2014 | HarvoniNDA 205834 · New molecular entity, new combination | Gilead Sciences Inc | 20 | Marketed |
| Aug 28, 2019 | HarvoniNDA 212477 · New dosage form | Gilead Sciences Inc | 5 | 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
