FDA — authorised 23 July 2018
- Marketing authorisation holder: ABBVIE INC
- Status: approved
🇺🇸 Orilissa in United States
FDA authorised Orilissa on 23 July 2018
Marketing authorisations
FDA — authorised 23 July 2018
- Application: NDA210450
- Marketing authorisation holder: ABBVIE
- Local brand name: ORILISSA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA217690
- Marketing authorisation holder: HETERO LABS LIMITED
- Local brand name: ELAGOLIX
- Indication: TABLET
- Status: approved
Orilissa 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 Orilissa approved in United States?
Yes. FDA authorised it on 23 July 2018; FDA authorised it on 23 July 2018; FDA has authorised it.
Who is the marketing authorisation holder for Orilissa in United States?
ABBVIE INC holds the US marketing authorisation.