Active substance
Dactinomycin
- US FDA 7
- Health Canada 1
- WHO EML 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DACTINOMYCIN | 0.5MG/VIAL | injectable · injection | EUGIA PHARMA | Prescription | 9 Nov 2017 |
| DACTINOMYCIN | 0.5MG/VIAL | injectable · injection | XGEN PHARMS | Prescription | 20 May 2019 |
| DACTINOMYCIN | 0.5MG/VIAL | injectable · injection | HISUN PHARM HANGZHOU | Prescription | 16 Jul 2019 |
| DACTINOMYCIN | 0.5MG/VIAL | injectable · injection | MEITHEAL | Prescription | 13 Nov 2020 |
| COSMEGEN | 0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | RECORDATI RARE | Discontinued | 10 Dec 1964 |
| DACTINOMYCIN | 0.5MG/VIAL | injectable · injection | HIKMA PHARMS | Discontinued | 16 Mar 2010 |
| DACTINOMYCIN | 0.5MG/VIAL | injectable · injection | AM REGENT | Discontinued | 23 Aug 2013 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| COSMEGEN | 00213071 | 0.5 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | RECORDATI RARE DISEASES CANADA INC |
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Rhabdomyosarcoma primary site; Malignant trophoblastic neoplasms of placenta; Ewing sarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of kidney, except renal pelvis
Parenteral > General injections > IV: 500 µg in vial powder for injection
Safety signals and safety-related labeling changes
- US FDA 15 Aug 2018 COSMEGEN — 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.