FDA — authorised 7 April 2014
- Application: NDA022567
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
🇺🇸 Viibryd in United States
FDA authorised Viibryd on 7 April 2014
Marketing authorisations
FDA — authorised 7 June 2023
- Application: ANDA208209
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 3 January 2024
- Application: ANDA208202
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
The FDA approved Viibryd for labeling indication on 2024-01-03. ALEMBIC is the marketing authorisation holder. The approval was granted under the standard expedited pathway.
FDA — authorised 3 January 2025
- Application: ANDA208200
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Viibryd for labeling indications on 2025-01-03. The marketing authorisation holder is INVAGEN PHARMS. The application number for this approval is ANDA208200. This approval was granted under the standard expedited pathway.
FDA — authorised 14 January 2025
- Application: ANDA208212
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
The FDA approved Viibryd for marketing in the United States on 14 January 2025. The approval was granted to TEVA PHARMS USA under the standard expedited pathway. The application number for this approval is ANDA208212.
Viibryd in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Viibryd approved in United States?
Yes. FDA authorised it on 7 April 2014; FDA authorised it on 7 June 2023; FDA authorised it on 3 January 2024.
Who is the marketing authorisation holder for Viibryd in United States?
ABBVIE holds the US marketing authorisation.