FDA — authorised 1 February 2021
- Application: NDA204803
- Marketing authorisation holder: INNOCOLL
- Local brand name: POSIMIR
- Indication: SOLUTION — INFILTRATION
- Status: approved
🇺🇸 Epidural anesthesia in United States
FDA authorised Epidural anesthesia on 1 February 2021 · 20 US adverse-event reports
Marketing authorisations
FDA — authorised 12 May 2021
- Application: NDA211988
- Marketing authorisation holder: HERON THERAPS INC
- Local brand name: ZYNRELEF KIT
- Indication: SOLUTION, EXTENDED RELEASE — PERIARTICULAR
- 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: 20
Most-reported reactions
- Premature Baby — 4 reports (20%)
- Drug Exposure During Pregnancy — 2 reports (10%)
- Drug Interaction — 2 reports (10%)
- Foetal Exposure During Pregnancy — 2 reports (10%)
- Jaundice — 2 reports (10%)
- Paralysis — 2 reports (10%)
- Pulmonary Oedema — 2 reports (10%)
- Respiratory Depression — 2 reports (10%)
- Activities Of Daily Living Impaired — 1 report (5%)
- Alopecia — 1 report (5%)
Epidural anesthesia 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 Epidural anesthesia approved in United States?
Yes. FDA authorised it on 1 February 2021; FDA authorised it on 12 May 2021; FDA has authorised it.
Who is the marketing authorisation holder for Epidural anesthesia in United States?
INNOCOLL holds the US marketing authorisation.