SOFOSBUVIR Pharmacologic Class Indexing
- Class set ID
- d67d79cd-4bb4-4769-a6f4-c074bb9b8713
- Version
- 3
- Effective date
- 20210728
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use VOSEVI safely and effectively. See full prescribing information for VOSEVI. VOSEVI ® (sofosbuvir, velpatasvir, and voxilaprevir) tablets, for oral use Initial U.S. Approval: 2017 | Gilead Sciences, Inc. | 20250714 | 6 |
| These highlights do not include all the information needed to use HARVONI™ safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014 | Gilead Sciences, Inc | 20250616 | 10 |
| These highlights do not include all the information needed to use EPCLUSA safely and effectively. See full prescribing information for EPCLUSA. EPCLUSA™ (sofosbuvir and velpatasvir) tablets, for oral use Initial U.S. Approval: 2016 GILEAD ACCESS PROGRAM | Gilead Sciences, Inc. | 20250424 | 6 |
| These highlights do not include all the information needed to use SOFOSBUVIR and VELPATASVIR TABLETS safely and effectively. See full prescribing information for SOFOSBUVIR and VELPATASVIR TABLETS. SOFOSBUVIR and VELPATASVIR tablets, for oral use, 400 mg/100 mg (Authorized generic of EPCLUSA ® ) Initial U.S. Approval: 2016 | Asegua Therapeutics LLC | 20250306 | 9 |
| These highlights do not include all the information needed to use LEDIPASVIR and SOFOSBUVIR TABLETS safely and effectively. See full prescribing information for LEDIPASVIR and SOFOSBUVIR TABLETS. LEDIPASVIR and SOFOSBUVIR tablets, for oral use, 90 mg/400 mg (Authorized generic of HARVONI ® ) Initial U.S. Approval: 2014 | Asegua Therapeutics LLC | 20250110 | 8 |
| These highlights do not include all the information needed to use HARVONI ® safely and effectively. See full prescribing information for HARVONI. HARVONI ® (ledipasvir and sofosbuvir) tablets, for oral use HARVONI ® (ledipasvir and sofosbuvir) oral pellets Initial U.S. Approval: 2014 | Gilead Sciences, Inc | 20241226 | 17 |
| These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI. SOVALDI ® (sofosbuvir) tablets, for oral use SOVALDI ® (sofosbuvir) oral pellets Initial U.S. Approval: 2013 | Gilead Sciences, Inc. | F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. | 20241226 | 16 |
| These highlights do not include all the information needed to use EPCLUSA safely and effectively. See full prescribing information for EPCLUSA. EPCLUSA ® (sofosbuvir and velpatasvir) tablets, for oral use EPCLUSA ® (sofosbuvir and velpatasvir) oral pellets Initial U.S. Approval: 2016 | Gilead Sciences, Inc. | 20240605 | 14 |
| These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI. GILEAD ACCESS PROGRAM SOVALDI™ (sofosbuvir) tablets, for oral use Initial U.S. Approval: 2013 | Gilead Sciences, Inc. | 20201220 | 9 |