FDA — authorised 2 July 2015
- Application: NDA206038
- Marketing authorisation holder: VERTEX PHARMS INC
- Local brand name: ORKAMBI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Symdeko in United States
FDA authorised Symdeko on 2 July 2015 · 3,414 US adverse-event reports
Marketing authorisations
FDA — authorised 7 August 2018
- Application: NDA211358
- Marketing authorisation holder: VERTEX PHARMS INC
- Local brand name: ORKAMBI
- Indication: GRANULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA216074
- Marketing authorisation holder: LUPIN LTD
- Local brand name: IVACAFTOR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA217431
- Marketing authorisation holder: LUPIN LTD
- Local brand name: IVACAFTOR
- Indication: GRANULE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 3,414
Most-reported reactions
- Infective Pulmonary Exacerbation Of Cystic Fibrosis — 1,181 reports (34.59%)
- Hospitalisation — 459 reports (13.44%)
- Infection — 352 reports (10.31%)
- Cystic Fibrosis — 288 reports (8.44%)
- Pneumonia — 285 reports (8.35%)
- Headache — 214 reports (6.27%)
- Cough — 183 reports (5.36%)
- Cystic Fibrosis Respiratory Infection Suppression — 168 reports (4.92%)
- Pulmonary Function Test Decreased — 144 reports (4.22%)
- Nausea — 140 reports (4.1%)
Symdeko in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Symdeko approved in United States?
Yes. FDA authorised it on 2 July 2015; FDA authorised it on 7 August 2018; FDA has authorised it.
Who is the marketing authorisation holder for Symdeko in United States?
VERTEX PHARMS INC holds the US marketing authorisation.