Prescription medicine
Busulfan Brand names: Myleran
Busulfan (Myleran) is a prescription medicine with an FDA approval on record since 1954. FDA's NDC Directory lists it from 7 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the busulfan FDA label on DailyMed (effective June 27, 2024, Eugia US LLC); the NDA 9386 record on Drugs@FDA; every busulfan label on DailyMed.
Highlights of the record
FDA label of June 27, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
MYELOSUPPRESSION.
Busulfan injection causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression [see Warnings and Precautions (5.1) ]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Causes severe and prolonged myelosuppression. ( 5.1 ) Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression.
Used for
From the label: indications and usageBusulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Forms and strengths
- 2 mg
- 6 mg/ml
Injection (solution); injection; film-coated tablet; injection (solution) (concentrate).
On the market
- Earliest approval on file
- June 26, 1954 Myleran, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first December 22, 2015; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 1 since 2020 0 Class I among all firms' recalls; latest May 4, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 15,644 through July 30, 2026
What is busulfan used for?
From the label: indications and usageBusulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Busulfan injection is an alkylating drug indicated for: Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML)
Conditions named in the indications of busulfan's FDA labels, with every medicine labeled for each:
From other busulfan labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (Busulfan), Eugia US LLC, effective June 27, 2024 (SPL set 06883ac0-4b2a-4f26-89bf-512d37b9ba7f), via openFDA; the full label on DailyMed
Is there a generic for busulfan (Myleran)?
The FDA approved the first generic busulfan on December 22, 2015. 15 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists busulfan from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1954 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is busulfan in shortage?
No busulfan presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated October 24, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Busulfan, Injection, 6 mg/1 mL (NDC 67457-893-08) | Mylan Institutional, a Viatris Company | To Be Discontinued | October 24, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has busulfan been recalled?
The FDA's Enforcement Report lists 2 recalls naming busulfan since 2020: 0 Class I (the most serious), 1 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of busulfan and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 4, 2026 | Class III | Sagent Pharmaceuticals | Failed Impurities/Degradation Specifications |
| December 8, 2020 | Class II | Shilpa Medicare Limited not a listed maker | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the busulfan label say about other medicines?
The busulfan label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name busulfan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | DRUG INTERACTIONS Drugs that Decrease Busulfan Clearance: Metronidazole, itraconazole, iron chelating agents, acetaminophen. ( 7.1 ) Drugs that Increase Busulfan Clearance: |
| Cyclophosphamide | warnings and precautions | Advise of potential risk to a fetus and use of effective contraception ( 5.4 , 8.1 , 8.3 ) Cardiac tamponade has been reported in pediatric patients with thalassemia who received high doses of oral busulfan and cyclophosphamide. |
| Deferasirox | drug interactions | Decreased clearance of busulfan was observed with concomitant use with deferasirox. |
| Divalproex | warnings and precautions | Initiate phenytoin therapy or any other alternative anti-convulsant prophylactic therapy (e.g., benzodiazepines, valproic acid or levetiracetam) prior to busulfan treatment [see Dosage and Administration (2.1) ]. |
| Filgrastim | warnings and precautions | The absolute neutrophil count recovered at a median of 13 days following allogeneic transplantation when prophylactic filgrastim was used in the majority of patients. |
| Fluconazole | drug interactions | Fluconazole (200 mg) has been used with busulfan. |
| Itraconazole | drug interactions | DRUG INTERACTIONS Drugs that Decrease Busulfan Clearance: Metronidazole, itraconazole, iron chelating agents, acetaminophen. ( 7.1 ) Drugs that Increase Busulfan Clearance: |
| Levetiracetam | warnings and precautions | Initiate phenytoin therapy or any other alternative anti-convulsant prophylactic therapy (e.g., benzodiazepines, valproic acid or levetiracetam) prior to busulfan treatment [see Dosage and Administration (2.1) ]. |
| Metronidazole | drug interactions | DRUG INTERACTIONS Drugs that Decrease Busulfan Clearance: Metronidazole, itraconazole, iron chelating agents, acetaminophen. ( 7.1 ) Drugs that Increase Busulfan Clearance: |
| Phenytoin | drug interactions | Drugs that Increase Busulfan Clearance Phenytoin increases the clearance of busulfan by 15% or more, possibly due to the induction of glutathione-S-transferase. |
| Thioguanine | drug interactions | Long-term continuous therapy with thioguanine and busulfan should be used with caution. |
| Valproic acid | warnings and precautions | Initiate phenytoin therapy or any other alternative anti-convulsant prophylactic therapy (e.g., benzodiazepines, valproic acid or levetiracetam) prior to busulfan treatment [see Dosage and Administration (2.1) ]. |
Other labels that name busulfan
Source: FDA drug label (Busulfan), Eugia US LLC, effective June 27, 2024 (SPL set 06883ac0-4b2a-4f26-89bf-512d37b9ba7f), via openFDA; the full label on DailyMed
What do FAERS reports show for busulfan?
The FDA Adverse Event Reporting System holds 15,644 reports that list busulfan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,592 are coded as a death and 3,233 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Busulfan side effects
- the label's list beside FAERS reports
- Busulfan shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other