Myleran

Treats chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. NDA 9386, held by Waylis Therap. Busulfan.

As of Nov 13, 2026, NDA 9386 (Myleran), held by Waylis Therap, was first approved by FDA on Jun 26, 1954, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 26, 1954
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 26, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Myleran2MG · tablet;oral	Busulfan	RxReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 24, 2003	Supplement 23Labeling · Standard review	Approved	Label Letter
Apr 16, 2003	Supplement 21Labeling · Standard review	Approved	Letter Label
Jan 23, 2003	Supplement 19Manufacturing · Priority review	Approved	Review Label Letter
Sep 20, 2002	Supplement 20Labeling · Standard review	Approved	None posted
Sep 6, 2000	Supplement 18Labeling · Standard review	Approved	None posted
Mar 15, 2000	Supplement 17Labeling · Standard review	Approved	None posted
Dec 23, 1997	Supplement 16Manufacturing · Priority review	Approved	None posted
Jul 29, 1994	Supplement 15Labeling · Standard review	Approved	None posted
Jul 15, 1991	Supplement 13Labeling	Approved	Label
Sep 17, 1990	Supplement 12Labeling	Approved	None posted
Mar 20, 1990	Supplement 11Manufacturing · Priority review	Approved	None posted
Apr 9, 1987	Supplement 9Labeling	Approved	None posted
Apr 9, 1987	Supplement 10Labeling	Approved	None posted
May 19, 1986	Supplement 8Labeling	Approved	None posted
May 11, 1981	Supplement 7Labeling	Approved	None posted
Nov 8, 1979	Supplement 6Labeling	Approved	None posted
Feb 10, 1977	Supplement 5Manufacturing · Priority review	Approved	None posted
Nov 21, 1975	Supplement 4REMS · Priority review	Approved	None posted
Jun 26, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 9386
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