FDA — authorised 17 December 2014
- Marketing authorisation holder: ALCON RES LTD
- Status: approved
🇺🇸 Xtoro in United States
FDA authorised Xtoro on 17 December 2014
Marketing authorisations
FDA — authorised 17 December 2014
- Application: NDA206307
- Marketing authorisation holder: FONSECA BIOSCIENCES
- Local brand name: XTORO
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
Xtoro 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 Xtoro approved in United States?
Yes. FDA authorised it on 17 December 2014; FDA authorised it on 17 December 2014.
Who is the marketing authorisation holder for Xtoro in United States?
ALCON RES LTD holds the US marketing authorisation.