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mitotane

FDA Drug Profile — Lysodren

Drug Details

Generic Name
mitotane
Brand Names
Lysodren
Application Number
NDA016885
Sponsor
ESTEVE PHARMACEUTICALS, S.A.
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
MITOTANE

Indications and Usage

1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). ( 1 )