FDA — authorised 13 February 2019
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
🇺🇸 Egaten in United States
FDA authorised Egaten on 13 February 2019
Marketing authorisations
FDA — authorised 13 February 2019
- Application: NDA208711
- Marketing authorisation holder: NOVARTIS
- Local brand name: EGATEN
- Indication: TABLET — ORAL
- Status: approved
Egaten in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Egaten approved in United States?
Yes. FDA authorised it on 13 February 2019; FDA authorised it on 13 February 2019.
Who is the marketing authorisation holder for Egaten in United States?
NOVARTIS PHARMS CORP holds the US marketing authorisation.