FDA — authorised 20 October 2006
- Marketing authorisation holder: TAKEDA GMBH
- Status: approved
🇺🇸 Omnaris in United States
FDA authorised Omnaris on 20 October 2006
Marketing authorisations
FDA — authorised 21 November 2007
- Application: NDA022124
- Marketing authorisation holder: NYCOMED US INC
- Local brand name: OMNARIS
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 22 December 2008
- Application: NDA021658
- Marketing authorisation holder: COVIS
- Indication: Labeling
- Status: approved
FDA — authorised 7 May 2010
- Application: NDA022004
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
Omnaris in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Omnaris approved in United States?
Yes. FDA authorised it on 20 October 2006; FDA authorised it on 21 November 2007; FDA authorised it on 22 December 2008.
Who is the marketing authorisation holder for Omnaris in United States?
TAKEDA GMBH holds the US marketing authorisation.