FDA — authorised 21 May 2020
- Application: NDA210875
- Marketing authorisation holder: SUMITOMO PHARMA AM
- Local brand name: KYNMOBI
- Indication: FILM — SUBLINGUAL
- Status: approved
🇺🇸 SL-APO in United States
FDA authorised SL-APO on 21 May 2020
Marketing authorisation
Frequently asked questions
Is SL-APO approved in United States?
Yes. FDA authorised it on 21 May 2020.
Who is the marketing authorisation holder for SL-APO in United States?
SUMITOMO PHARMA AM holds the US marketing authorisation.