Ellence

NDA 50778, held by Pfizer Inc. Epirubicin Hydrochloride.

As of Nov 14, 2026, NDA 50778 (Ellence), held by Pfizer Inc, was first approved by FDA on Sep 15, 1999, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1999
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Mar 2, 2005	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 15, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Ellence200MG/100ML (2MG/ML) · injectable;injection	Epirubicin Hydrochloride	RxReference drug
Ellence50MG/25ML (2MG/ML) · injectable;injection	Epirubicin Hydrochloride	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Nov 25, 2024	Supplement 29Manufacturing	Approved	Label Letter
Feb 18, 2021	Supplement 26Labeling · Standard review	Approved	Letter
Jul 26, 2019	Supplement 24Labeling · Standard review	Approved	Label Letter
Jul 26, 2019	Supplement 25Labeling · Standard review	Approved	Letter Label
Dec 15, 2014	Supplement 21Labeling · Standard review	Approved	Letter Label
Feb 19, 2013	Supplement 19Labeling · Standard review	Approved	Letter Label
Sep 14, 2011	Supplement 15Labeling · Standard review	Approved	Letter Label
Sep 14, 2011	Supplement 17Labeling	Approved	Letter Label
Sep 14, 2011	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 2, 2005	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 3, 2003	Supplement 3Labeling · Priority review	Approved	Letter
Apr 3, 2003	Supplement 4Labeling · Standard review	Approved	Letter
Jul 20, 2000	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 15, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 50778
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters