FDA — authorised 28 September 2021
- Application: NDA215110
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
🇺🇸 PIBRENTASVIR in United States
FDA authorised PIBRENTASVIR on 28 September 2021 · 465 US adverse-event reports
Marketing authorisations
FDA — authorised 10 June 2025
- Application: NDA209394
- Marketing authorisation holder: ABBVIE
- Indication: Efficacy
- Status: approved
The FDA approved PIBRENTASVIR, a drug developed by AbbVie, for its approved indication on 10 June 2025. The application number for this approval is NDA209394. PIBRENTASVIR was granted marketing authorisation through the standard expedited pathway.
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 465
Most-reported reactions
- Death — 66 reports (14.19%)
- Drug Interaction — 59 reports (12.69%)
- Nausea — 50 reports (10.75%)
- Hepatitis C — 48 reports (10.32%)
- Headache — 47 reports (10.11%)
- Fatigue — 46 reports (9.89%)
- Hepatocellular Carcinoma — 43 reports (9.25%)
- Pruritus — 39 reports (8.39%)
- Vomiting — 37 reports (7.96%)
- Malaise — 30 reports (6.45%)
PIBRENTASVIR in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is PIBRENTASVIR approved in United States?
Yes. FDA authorised it on 28 September 2021; FDA authorised it on 10 June 2025.
Who is the marketing authorisation holder for PIBRENTASVIR in United States?
ABBVIE holds the US marketing authorisation.