dactinomycin for injection
for intravenous use Initial U.S. Approval: 1964
dactinomycin for injection as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment of Wilms’ tumor, childhood rhabdomyosarcoma, Ewing’s sarcoma and metastatic, nonseminomatous testicular cancer. COSMEGEN is indicated as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia. COSMEGEN, as a component of regional perfusion, is indicated for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.
Facts about Dactinomycin Injection
Approval Date: 1964
Proprietary Name: On Request
Active Ingredient(s): Dactinomycin Injection
Dosage Forms And Strengths: For injection: 500 mcg as a lyophilized powder in a single-dose vial.
Manufacturer:
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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