FDA — authorised 21 December 2015
- Application: NDA207947
- Marketing authorisation holder: ACTELION
- Status: supplemented
🇺🇸 titration in United States
FDA authorised titration on 21 December 2015 · 21 US adverse-event reports
Marketing authorisations
FDA — authorised 21 November 2019
- Application: NDA212839
- Marketing authorisation holder: SK LIFE
- Status: supplemented
FDA — authorised 21 December 2022
- Application: ANDA214302
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA
- 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: 28 March 2025 – 28 March 2026
- Total reports: 21
Most-reported reactions
- Death — 3 reports (14.29%)
- Oedema Peripheral — 3 reports (14.29%)
- Arterial Occlusive Disease — 2 reports (9.52%)
- Drug Ineffective — 2 reports (9.52%)
- Headache — 2 reports (9.52%)
- Insomnia — 2 reports (9.52%)
- Myocardial Infarction — 2 reports (9.52%)
- Nausea — 2 reports (9.52%)
- Vomiting — 2 reports (9.52%)
- Acute Hepatic Failure — 1 report (4.76%)
Other Other approved in United States
Frequently asked questions
Is titration approved in United States?
Yes. FDA authorised it on 21 December 2015; FDA authorised it on 21 November 2019; FDA authorised it on 21 December 2022.
Who is the marketing authorisation holder for titration in United States?
ACTELION holds the US marketing authorisation.