FDA — authorised 30 June 2011
- Application: NDA022569
- Marketing authorisation holder: BTCP PHARMA
- Local brand name: LAZANDA
- Indication: SPRAY, METERED — NASAL
- Status: approved
🇺🇸 Fentanyl Nasal Spray in United States
FDA authorised Fentanyl Nasal Spray on 30 June 2011 · 3 US adverse-event reports
Marketing authorisations
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 3
Most-reported reactions
- Cleft Palate — 1 report (33.33%)
- Death — 1 report (33.33%)
- Foetal Exposure During Pregnancy — 1 report (33.33%)
Fentanyl Nasal Spray 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 Fentanyl Nasal Spray approved in United States?
Yes. FDA authorised it on 30 June 2011; FDA has authorised it.
Who is the marketing authorisation holder for Fentanyl Nasal Spray in United States?
BTCP PHARMA holds the US marketing authorisation.