Quick answers
- What is Sofosbuvir used for?
- The FDA-approved label (Sovaldi, Gilead Sciences, Inc., December 26, 2024) says: “SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sofosbuvir have a boxed warning?
- Yes. The FDA label for Sovaldi has a boxed warning (“WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sofosbuvir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sofosbuvir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sofosbuvir?
- 1 company lists prescription products of Sofosbuvir in the FDA NDC Directory, including Gilead Sciences, Inc..
What Sofosbuvir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. …
— FDA label: Sovaldi, Gilead Sciences, Inc., effective December 26, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated · Pellet |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Sovaldi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Gilead Sciences, Inc.4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204671 SOVALDI | Gilead Sciences Inc | December 6, 2013 | 12, latest December 23, 2024 2024: Labeling · 2020: Labeling · 2020: Labeling |
| NDA212480 SOVALDI | Gilead Sciences Inc | August 28, 2019 | 4, latest December 23, 2024 2024: Labeling · 2020: Labeling · 2019: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sovaldi, Gilead Sciences, Inc., effective December 26, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →