FDA — authorised 11 March 1998
- Application: ANDA040235
- Marketing authorisation holder: HIKMA
- Local brand name: PHENTOLAMINE MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 OraVerse in United States
FDA authorised OraVerse on 11 March 1998 · 30 US adverse-event reports
Marketing authorisations
FDA — authorised 9 May 2008
- Application: NDA022159
- Marketing authorisation holder: SEPTODONT HOLDING
- Local brand name: ORAVERSE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 July 2017
- Application: ANDA207686
- Marketing authorisation holder: PRECISION DOSE INC
- Local brand name: PHENTOLAMINE MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 September 2023
- Application: NDA217064
- Marketing authorisation holder: FAMYGEN LIFE SCI
- Local brand name: RYZUMVI
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
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: 30
Most-reported reactions
- Hypoaesthesia — 6 reports (20%)
- Swelling Face — 5 reports (16.67%)
- Injection Site Pain — 4 reports (13.33%)
- Facial Pain — 3 reports (10%)
- Burning Sensation — 2 reports (6.67%)
- Cardiovascular Disorder — 2 reports (6.67%)
- Discomfort — 2 reports (6.67%)
- Dizziness — 2 reports (6.67%)
- Haemorrhage — 2 reports (6.67%)
- Nausea — 2 reports (6.67%)
OraVerse 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 OraVerse approved in United States?
Yes. FDA authorised it on 11 March 1998; FDA authorised it on 9 May 2008; FDA authorised it on 14 July 2017.
Who is the marketing authorisation holder for OraVerse in United States?
HIKMA holds the US marketing authorisation.