FDA — authorised 14 December 2017
- Application: NDA209963
- Marketing authorisation holder: LXO IRELAND
- Local brand name: GOPRELTO
- Indication: SOLUTION — NASAL
- Status: approved
🇺🇸 Goprelto in United States
FDA authorised Goprelto on 14 December 2017
Marketing authorisations
FDA — authorised 27 August 2020
- Application: NDA209575
- Marketing authorisation holder: OMNIVIUM PHARMS
- Indication: Labeling
- Status: approved
Goprelto in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Goprelto approved in United States?
Yes. FDA authorised it on 14 December 2017; FDA authorised it on 27 August 2020.
Who is the marketing authorisation holder for Goprelto in United States?
LXO IRELAND holds the US marketing authorisation.