🇺🇸 SPARSENTAN in United States

FDA authorised SPARSENTAN on 17 February 2023 · 40 US adverse-event reports

Marketing authorisations

FDA — authorised 17 February 2023

  • Application: NDA216403
  • Marketing authorisation holder: TRAVERE
  • Local brand name: FILSPARI
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Proteinuria — 6 reports (15%)
  2. Hypotension — 5 reports (12.5%)
  3. Abdominal Pain Upper — 4 reports (10%)
  4. Acute Kidney Injury — 4 reports (10%)
  5. Inappropriate Schedule Of Product Administration — 4 reports (10%)
  6. Off Label Use — 4 reports (10%)
  7. Urinary Tract Infection — 4 reports (10%)
  8. Anaemia — 3 reports (7.5%)
  9. Drug Ineffective — 3 reports (7.5%)
  10. Headache — 3 reports (7.5%)

Source database →

SPARSENTAN in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is SPARSENTAN approved in United States?

Yes. FDA authorised it on 17 February 2023; FDA has authorised it.

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

TRAVERE holds the US marketing authorisation.