FDA — authorised 12 February 2018
- Marketing authorisation holder: VERTEX PHARMS
- Status: approved
🇺🇸 Symdeko (Copackaged) in United States
FDA authorised Symdeko (Copackaged) on 12 February 2018
Marketing authorisations
FDA — authorised 12 February 2018
- Application: NDA210491
- Marketing authorisation holder: VERTEX PHARMS INC
- Local brand name: SYMDEKO (COPACKAGED)
- Indication: TABLET — ORAL
- Status: approved
Symdeko (Copackaged) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Symdeko (Copackaged) approved in United States?
Yes. FDA authorised it on 12 February 2018; FDA authorised it on 12 February 2018.
Who is the marketing authorisation holder for Symdeko (Copackaged) in United States?
VERTEX PHARMS holds the US marketing authorisation.