Active substance
Corticotropin
- US FDA 9
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ACTHAR GEL (AUTOINJECTOR) | 40 UNITS/0.5ML; 80 UNITS/ML | injectable · injection | MALLINCKRODT IRELAND | Prescription | 29 Apr 1952 |
| ACTHAR GEL | 80 UNITS/ML | injectable · injection | MALLINCKRODT IRELAND | Prescription | 29 Apr 1952 |
| PURIFIED CORTROPHIN GEL | 80 UNITS/ML | injectable · injection | ANI PHARMS | Prescription | 16 Jun 1954 |
| ACTHAR | 25 UNITS/VIAL; 40 UNITS/VIAL | injectable · injection | SANOFI AVENTIS US | Discontinued | 3 Jul 1950 |
| ACTH | 25 UNITS/VIAL; 40 UNITS/VIAL | injectable · injection | PARKEDALE | Discontinued | 14 Mar 1952 |
| ACTHAR GEL | 40 UNITS/ML | injectable · injection | MALLINCKRODT IRELAND | Discontinued | 29 Apr 1952 |
| PURIFIED CORTROPHIN GEL | 40 UNITS/ML | injectable · injection | ANI PHARMS | Discontinued | 16 Jun 1954 |
| CORTICOTROPIN | 40 UNITS/ML; 80 UNITS/ML | injectable · injection | ORGANICS LAGRANGE | Discontinued | 12 Sep 1957 |
| CORTICOTROPIN | 40 UNITS/VIAL | injectable · injection | WATSON LABS | Discontinued |
Safety signals and safety-related labeling changes
- US FDA 29 Feb 2024 ACTHAR GEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 26 Oct 2023 PURIFIED CORTROPHIN GEL — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 2 Mar 2021 H.P. ACTHAR GEL — safety-related labeling change
Labeling sections changed: Contraindications; 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.