Gleostine

As of Nov 13, 2026, NDA 17588 (Gleostine), held by Azurity, was first approved by FDA on Aug 4, 1976, with 35 approved supplements and 0 published complete response letters.

First approved: Aug 4, 1976
Review: Standard
Supplements approved: 35
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gleostine is an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. 1.1 Brain Tumors Gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 Hodgkin's Lymphoma Gleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Aug 4, 1976	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


Gleostine10MG · capsule;oral	Lomustine	RxReference drug
Gleostine40MG · capsule;oral	Lomustine	RxReference drug
Gleostine100MG · capsule;oral	Lomustine	RxReference drug
Gleostine5MG · capsule;oral	Lomustine	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Jun 4, 2020	Supplement 46Manufacturing	Approved	Label Letter
Jan 29, 2016	Supplement 43Labeling · Standard review	Approved	Label Letter
Jan 6, 2016	Supplement 42Labeling · Standard review	Approved	Letter Label
Jan 5, 2015	Supplement 41Manufacturing · Standard review	Approved	None posted
May 20, 2014	Supplement 40Labeling · Standard review	Approved	Label Letter
Aug 15, 2013	Supplement 39Labeling · Standard review	Approved	Label
Aug 14, 2013	Supplement 38Manufacturing · Standard review	Approved	None posted
Nov 21, 2012	Supplement 36Labeling · Standard review	Approved	Label Letter
May 12, 2011	Supplement 37Labeling · Standard review	Approved	Letter Label
Apr 30, 2009	Supplement 34Labeling · Standard review	Approved	Label Letter
Feb 27, 2003	Supplement 33Labeling · Standard review	Approved	Letter
Dec 20, 2002	Supplement 31Labeling · Standard review	Approved	Letter
Jun 1, 1999	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 2, 1993	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 14, 1991	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 29Manufacturing · Standard review	Approved	None posted
Nov 14, 1988	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 5, 1988	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 26, 1987	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 14, 1986	Supplement 11Labeling	Approved	None posted
Sep 22, 1986	Supplement 22Labeling	Approved	None posted
Sep 22, 1986	Supplement 20Labeling	Approved	None posted
Sep 12, 1986	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 12, 1986	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 18, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 6, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 22, 1983	Supplement 12Labeling	Approved	None posted
Jun 28, 1983	Supplement 15Labeling	Approved	None posted
Feb 16, 1982	Supplement 10Labeling	Approved	None posted
Nov 12, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 12, 1980	Supplement 8Labeling	Approved	None posted
Sep 19, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 7, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 14, 1978	Supplement 4Labeling	Approved	None posted
Apr 22, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 4, 1976	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17588
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

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