🇺🇸 Striverdi in United States

FDA authorised Striverdi on 31 July 2014 · 221 US adverse-event reports

Marketing authorisations

FDA — authorised 31 July 2014

  • Application: NDA203108
  • Marketing authorisation holder: BOEHRINGER INGELHEIM
  • Status: supplemented

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.

Most-reported reactions

  1. Dyspnoea — 53 reports (23.98%)
  2. Cough — 34 reports (15.38%)
  3. Off Label Use — 31 reports (14.03%)
  4. Drug Ineffective — 29 reports (13.12%)
  5. Asthma — 14 reports (6.33%)
  6. Chest Pain — 14 reports (6.33%)
  7. Chronic Obstructive Pulmonary Disease — 13 reports (5.88%)
  8. Asthenia — 12 reports (5.43%)
  9. Chest Discomfort — 11 reports (4.98%)
  10. Insomnia — 10 reports (4.52%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Striverdi approved in United States?

Yes. FDA authorised it on 31 July 2014; FDA has authorised it.

Who is the marketing authorisation holder for Striverdi in United States?

BOEHRINGER INGELHEIM holds the US marketing authorisation.