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epirubicin hydrochloride

FDA Drug Profile — Ellence

Drug Details

Generic Name
epirubicin hydrochloride
Brand Names
Ellence
Application Number
NDA050778
Sponsor
Pharmacia & Upjohn Company LLC
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
EPIRUBICIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).