🇺🇸 ZAVEGEPANT in United States

FDA authorised ZAVEGEPANT on 9 March 2023 · 76 US adverse-event reports

Marketing authorisation

FDA — authorised 9 March 2023

  • Application: NDA216386
  • Marketing authorisation holder: PFIZER
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

Read official source →

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. Dysgeusia — 39 reports (51.32%)
  2. Drug Ineffective — 8 reports (10.53%)
  3. Nasal Discomfort — 8 reports (10.53%)
  4. Burning Sensation — 5 reports (6.58%)
  5. Throat Irritation — 4 reports (5.26%)
  6. Migraine — 3 reports (3.95%)
  7. Off Label Use — 3 reports (3.95%)
  8. Drug Ineffective For Unapproved Indication — 2 reports (2.63%)
  9. Nausea — 2 reports (2.63%)
  10. Taste Disorder — 2 reports (2.63%)

Source database →

ZAVEGEPANT 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 ZAVEGEPANT approved in United States?

Yes. FDA authorised it on 9 March 2023.

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

PFIZER holds the US marketing authorisation.