Quick answers
- What is Lomustine used for?
- The FDA-approved label (Gleostine, Azurity Pharmaceuticals, Inc., September 25, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lomustine have a boxed warning?
- Yes. The FDA label for Gleostine has a boxed warning (“WARNING: DELAYED MYELOSUPPRESSION AND RISK OF OVERDOSAGE DELAYED MYELOSUPPRESSION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lomustine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lomustine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lomustine?
- 4 companies list prescription products of Lomustine in the FDA NDC Directory, including Azurity Pharmaceuticals, Inc., Wilshire Pharmaceuticals, Inc. and Carnegie Pharmaceuticals LLC.
What Lomustine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Gleostine, Azurity Pharmaceuticals, Inc., effective September 25, 2025. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: DELAYED MYELOSUPPRESSION AND RISK OF OVERDOSAGE DELAYED MYELOSUPPRESSION
. Read it on the full label →
4 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, gelatin coated · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Gleostine |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Azurity Pharmaceuticals, Inc.3 products
- Wilshire Pharmaceuticals, Inc.3 products
- Carnegie Pharmaceuticals LLC3 products
- NextSource Biotechnology, LLC3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017588 GLEOSTINE | Azurity | August 4, 1976 | 35, latest June 4, 2020 2020: Manufacturing (CMC) · 2016: Labeling · 2016: Labeling |
Generic approvals (1)
- ANDA219265Carnegie · October 27, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gleostine, Azurity Pharmaceuticals, Inc., effective September 25, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →