Prescription medicine
Dactinomycin First approved as Cosmegen
Dactinomycin (Cosmegen) is a prescription medicine with an FDA approval on record since 1964. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
Check it at the source: the dactinomycin FDA label on DailyMed (effective June 18, 2024, Eugia US LLC); the NDA 50682 record on Drugs@FDA; every dactinomycin label on DailyMed.
Highlights of the record
FDA label of June 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.
Forms and strengths
- 0.5 mg
- 0.5 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- December 10, 1964 Cosmegen, Recordati Rare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first March 16, 2010; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,189 through July 30, 2026
What is dactinomycin used for?
From the label: indications and usageDactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. ( 1.1 ) adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. ( 1.2 ) adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. ( 1.3 ) adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. […]
FDA pharmacologic class: Actinomycin.
Source: FDA drug label (DACTINOMYCIN), Eugia US LLC, effective June 18, 2024 (SPL set 5da55538-2602-4704-a9da-603c9f7ff7dc), via openFDA; the full label on DailyMed
Is there a generic for dactinomycin (Cosmegen)?
The FDA approved the first generic dactinomycin on March 16, 2010. 6 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dactinomycin from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1964 earliest approval on file
- 2010 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for dactinomycin?
The FDA Adverse Event Reporting System holds 2,189 reports that list dactinomycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 386 are coded as a death and 679 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Dactinomycin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other