Active substance
Amifostine
- US FDA 4
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ETHYOL | 500MG/VIAL | injectable · injection | LEGACY | Prescription | 8 Dec 1995 |
| ETHYOL | 375MG/VIAL | injectable · injection | LEGACY | Discontinued | 8 Dec 1995 |
| AMIFOSTINE | 500MG/VIAL | injectable · injection | SUN PHARM | Discontinued | 14 Mar 2008 |
| AMIFOSTINE | 500MG/VIAL | injectable · injection | EUGIA PHARMA SPECLTS | Discontinued | 17 Jul 2017 |
Safety signals and safety-related labeling changes
- US FDA 25 Jul 2019 ETHYOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.