🇺🇸 Sprix in United States

FDA authorised Sprix on 14 May 2010 · 359 US adverse-event reports

Marketing authorisations

FDA — authorised 14 May 2010

  • Application: NDA022382
  • Marketing authorisation holder: ZYLA
  • 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. Nasal Discomfort — 96 reports (26.74%)
  2. Off Label Use — 42 reports (11.7%)
  3. Drug Ineffective — 39 reports (10.86%)
  4. Sneezing — 37 reports (10.31%)
  5. Wrong Technique In Product Usage Process — 35 reports (9.75%)
  6. Migraine — 25 reports (6.96%)
  7. Burning Sensation — 22 reports (6.13%)
  8. Nausea — 21 reports (5.85%)
  9. Rhinorrhoea — 21 reports (5.85%)
  10. Throat Irritation — 21 reports (5.85%)

Source database →

Sprix in other countries

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

Other Other approved in United States

Frequently asked questions

Is Sprix approved in United States?

Yes. FDA authorised it on 14 May 2010; FDA has authorised it.

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

ZYLA holds the US marketing authorisation.