FDA — authorised 16 October 1981
- Application: NDA018484
- Marketing authorisation holder: PFIZER
- Local brand name: PROSTIN VR PEDIATRIC
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Eglandin in United States
FDA authorised Eglandin on 16 October 1981 · 15 US adverse-event reports
Marketing authorisations
FDA — authorised 12 June 1997
- Application: NDA020649
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: EDEX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 1999
- Application: ANDA075196
- Marketing authorisation holder: MEITHEAL
- Local brand name: ALPROSTADIL
- Indication: INJECTABLE — INJECTION
- 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: 28 March 2025 – 28 March 2026
- Total reports: 15
Most-reported reactions
- Multiple Organ Dysfunction Syndrome — 3 reports (20%)
- Venoocclusive Liver Disease — 3 reports (20%)
- Reversible Posterior Leukoencephalopathy Syndrome — 2 reports (13.33%)
- Abdominal Distension — 1 report (6.67%)
- Abdominal Pain Upper — 1 report (6.67%)
- Acute Kidney Injury — 1 report (6.67%)
- Anaemia — 1 report (6.67%)
- Aortic Aneurysm — 1 report (6.67%)
- Back Pain — 1 report (6.67%)
- Blood Pressure Increased — 1 report (6.67%)
Other Other approved in United States
Frequently asked questions
Is Eglandin approved in United States?
Yes. FDA authorised it on 16 October 1981; FDA authorised it on 12 June 1997; FDA authorised it on 30 April 1999.
Who is the marketing authorisation holder for Eglandin in United States?
PFIZER holds the US marketing authorisation.