Leukeran

Treats chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including…. NDA 10669, held by Waylis Therap. Chlorambucil.

As of Nov 13, 2026, NDA 10669 (Leukeran), held by Waylis Therap, was first approved by FDA on Mar 18, 1957, with 22 approved supplements and 0 published complete response letters.

First approved: Mar 18, 1957
Review: Priority
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Mar 18, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Leukeran2MG · tablet;oral	Chlorambucil	RxReference drug

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 28, 2011	Supplement 32Labeling	Approved	Letter Label
Apr 23, 2010	Supplement 30Labeling · Standard review	Approved	Label Letter
May 24, 2005	Supplement 29Labeling · Standard review	Approved	Letter
Nov 13, 2003	Supplement 28Labeling · Standard review	Approved	Label Letter
Nov 14, 2002	Supplement 25Manufacturing · Priority review	Approved	None posted
Jul 24, 2001	Supplement 23Manufacturing · Priority review	Approved	Letter
Jul 24, 2001	Supplement 22Manufacturing · Priority review	Approved	Letter
Jul 24, 2001	Supplement 21Manufacturing · Priority review	Approved	Letter
Jun 20, 2001	Supplement 24Labeling · Standard review	Approved	Letter
Feb 9, 1996	Supplement 17Labeling · Standard review	Approved	None posted
Jun 29, 1995	Supplement 20Manufacturing · Priority review	Approved	None posted
Feb 4, 1994	Supplement 18Manufacturing · Priority review	Approved	None posted
Oct 14, 1992	Supplement 16Manufacturing · Priority review	Approved	None posted
Mar 6, 1990	Supplement 14Manufacturing · Priority review	Approved	None posted
Feb 28, 1989	Supplement 15Labeling	Approved	None posted
Sep 22, 1986	Supplement 12Labeling	Approved	None posted
Mar 12, 1984	Supplement 11Labeling	Approved	None posted
Aug 27, 1981	Supplement 9Labeling	Approved	None posted
Feb 15, 1979	Supplement 6Manufacturing · Priority review	Approved	None posted
Jun 8, 1978	Supplement 8Manufacturing · Priority review	Approved	None posted
Mar 22, 1978	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 9, 1977	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 18, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10669
Drugs@FDA: Overview at FDA
Company: Waylis Therapeutics

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