Trabectedin

FDA Drug Profile — EVDI, YONDELIS

Trabectedin is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including EVDI, YONDELIS. Available dosage forms: injection, solution, concentrate, injection, powder, lyophilized, for solution, powder.

Drug Details

Generic Name
Trabectedin
Brand Names
EVDI, YONDELIS
Application Number
NDA220837
Sponsor
Apotex Corp.
NDC Codes
5
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
TRABECTEDIN

Indications and Usage

1 INDICATIONS AND USAGE EVDI 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) ] . EVDI 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 )