FDA — authorised 22 December 2015
- Application: ANDA202259
- Marketing authorisation holder: AM REGENT
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BUSULFAN in United States
FDA authorised BUSULFAN on 22 December 2015 · 10,731 US adverse-event reports
Marketing authorisations
FDA — authorised 24 March 2017
- Application: ANDA207050
- Marketing authorisation holder: PHARMASCIENCE INC
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 2017
- Application: ANDA208536
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Status: approved
FDA — authorised 8 December 2017
- Application: ANDA205139
- Marketing authorisation holder: ACTAVIS
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 2017
- Application: ANDA209580
- Marketing authorisation holder: AMNEAL
- Status: supplemented
FDA — authorised 13 July 2018
- Application: ANDA205184
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 July 2018
- Application: ANDA205672
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 September 2018
- Application: ANDA205106
- Marketing authorisation holder: ARTHUR GRP
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 January 2019
- Application: ANDA207794
- Marketing authorisation holder: NEXUS
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2019
- Application: ANDA210931
- Marketing authorisation holder: SHILPA
- Status: approved
FDA — authorised 7 May 2019
- Application: ANDA210448
- Marketing authorisation holder: APOTEX
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 October 2020
- Application: ANDA212127
- Marketing authorisation holder: MEITHEAL
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 June 2024
- Application: ANDA215102
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 September 2024
- Application: ANDA215235
- Marketing authorisation holder: PRINSTON INC
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 10,731
Most-reported reactions
- Off Label Use — 1,887 reports (17.58%)
- Product Use In Unapproved Indication — 1,545 reports (14.4%)
- Mucosal Inflammation — 1,041 reports (9.7%)
- Drug Ineffective — 1,030 reports (9.6%)
- Graft Versus Host Disease — 962 reports (8.96%)
- Venoocclusive Liver Disease — 917 reports (8.55%)
- Cytomegalovirus Infection — 868 reports (8.09%)
- Acute Graft Versus Host Disease — 853 reports (7.95%)
- Febrile Neutropenia — 819 reports (7.63%)
- Pyrexia — 809 reports (7.54%)
BUSULFAN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BUSULFAN approved in United States?
Yes. FDA authorised it on 22 December 2015; FDA authorised it on 24 March 2017; FDA authorised it on 20 November 2017.
Who is the marketing authorisation holder for BUSULFAN in United States?
AM REGENT holds the US marketing authorisation.