Trabectedin

FDA Drug Profile — YONDELIS

Drug Details

Generic Name
Trabectedin
Brand Names
YONDELIS
Application Number
NDA207953
Sponsor
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
NDC Codes
3
Dosage Forms
POWDER, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
TRABECTEDIN

Indications and Usage

1 INDICATIONS AND USAGE YONDELIS ® is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen [see Clinical Studies (14) ] . YONDELIS is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen ( 1 )