Idamycin Pfs, Idarubicin Hydrochloride

Treats acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. NDA 50734, held by Pfizer. Idarubicin Hydrochloride.

As of Nov 13, 2026, NDA 50734 (Idamycin Pfs, Idarubicin Hydrochloride), held by Pfizer, was first approved by FDA on Feb 17, 1997, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 17, 1997
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Feb 17, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Idamycin Pfs5MG/5ML (1MG/ML) · solution;intravenous	Idarubicin Hydrochloride	RxReference drug
Idarubicin Hydrochloride10MG/10ML (1MG/ML) · solution;intravenous	Idarubicin Hydrochloride	RxReference drug
Idarubicin Hydrochloride20MG/20ML (1MG/ML) · solution;intravenous	Idarubicin Hydrochloride	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 6, 2026	Supplement 32Labeling · Standard review	Approved	Label Letter
Nov 6, 2023	Supplement 31Manufacturing	Approved	Letter Label
Apr 27, 2022	Supplement 29Labeling · Standard review	Approved	Letter Label
Feb 10, 2021	Supplement 27Labeling · Standard review	Approved	Label Letter
Aug 2, 2019	Supplement 25Labeling · Standard review	Approved	Label Letter
Dec 4, 2014	Supplement 22Labeling · Standard review	Approved	Label Letter
May 1, 2003	Supplement 5Labeling · Standard review	Approved	Letter Label
Nov 5, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 2, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 21, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
May 31, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
May 31, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 7, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 12, 1999	Supplement 4Labeling · Standard review	Approved	None posted
Feb 17, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50734
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