FDA — authorised 12 October 2012
- Application: NDA201820
- Marketing authorisation holder: CHIESI
- Local brand name: BETHKIS
- Indication: SOLUTION — INHALATION
- Status: approved
FDA authorised Bethkis® on 12 October 2012
Yes. FDA authorised it on 12 October 2012.
CHIESI holds the US marketing authorisation.