Corluxin FGK Representative Service GmbH · Application withdrawn
Therapeutic indication (EMA)
Treatment of Cushings syndrome
Active substance
Mifepristone
- US FDA 5
- EMA 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MIFEPREX | 200MG | tablet · oral | DANCO LABS LLC | Prescription | 28 Sep 2000 |
| KORLYM | 300MG | tablet · oral | CORCEPT THERAP | Prescription | 17 Feb 2012 |
| MIFEPRISTONE | 200MG | tablet · oral | GENBIOPRO | Prescription | 11 Apr 2019 |
| MIFEPRISTONE | 300MG | tablet · oral | TEVA PHARMS USA INC | Prescription | 3 Aug 2020 |
| MIFEPRISTONE | 200MG | tablet · oral | EVITA SOLUTIONS | Prescription | 30 Sep 2025 |
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 3 Jan 2023 MIFEPREX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Nov 2019 KORLYM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; 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.