FDA — authorised 7 August 2020
- Marketing authorisation holder: TREVENA INC
- Status: approved
🇺🇸 Olinvyk in United States
FDA authorised Olinvyk on 7 August 2020
Marketing authorisations
FDA — authorised 7 August 2020
- Application: NDA210730
- Marketing authorisation holder: TREVENA
- Local brand name: OLINVYK
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The US FDA approved Olinvyk, a medication for pain management, on December 15, 2023. The approval was granted to TREVENA, the marketing authorisation holder, through a standard expedited pathway. Olinvyk is intended for use in adults with moderate to severe pain, as per the approved labeling.
Olinvyk 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 Olinvyk approved in United States?
Yes. FDA authorised it on 7 August 2020; FDA authorised it on 7 August 2020.
Who is the marketing authorisation holder for Olinvyk in United States?
TREVENA INC holds the US marketing authorisation.