🇺🇸 Intravenous Treprostinil in United States

FDA authorised Intravenous Treprostinil on 21 May 2002 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 21 May 2002

  • Application: NDA021272
  • Marketing authorisation holder: UNITED THERAP
  • Local brand name: REMODULIN
  • Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
  • Status: approved

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FDA — authorised 30 July 2018

  • Application: NDA208276
  • Marketing authorisation holder: UNITED THERAP
  • Local brand name: REMODULIN
  • Indication: SOLUTION — INTRAVENOUS, SUBCUTANEOUS
  • Status: approved

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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. Catheter Site Erythema — 1 report (10%)
  2. Catheter Site Infection — 1 report (10%)
  3. Catheter Site Pain — 1 report (10%)
  4. Catheter Site Related Reaction — 1 report (10%)
  5. Fluctuance — 1 report (10%)
  6. Infection — 1 report (10%)
  7. Purulent Discharge — 1 report (10%)
  8. Pyrexia — 1 report (10%)
  9. Skin Warm — 1 report (10%)
  10. Swelling — 1 report (10%)

Source database →

Frequently asked questions

Is Intravenous Treprostinil approved in United States?

Yes. FDA authorised it on 21 May 2002; FDA authorised it on 30 July 2018; FDA has authorised it.

Who is the marketing authorisation holder for Intravenous Treprostinil in United States?

UNITED THERAP holds the US marketing authorisation.