FDA — authorised 7 December 2015
- Application: NDA208194
- Marketing authorisation holder: EAGLE PHARMS
- Local brand name: BENDEKA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 BENDAMUSTINE HYDROCHLORIDE in United States
FDA authorised BENDAMUSTINE HYDROCHLORIDE on 7 December 2015 · 4,808 US adverse-event reports
Marketing authorisations
FDA — authorised 15 May 2018
- Application: NDA205580
- Marketing authorisation holder: EAGLE PHARMS
- Local brand name: BELRAPZO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 7 December 2022
- Application: NDA215033
- Marketing authorisation holder: APOTEX
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 7 December 2022
- Application: NDA212209
- Marketing authorisation holder: AZURITY
- Local brand name: VIVIMUSTA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 7 December 2022
- Application: ANDA205376
- Marketing authorisation holder: DR REDDYS
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 7 December 2022
- Application: ANDA205574
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 15 December 2022
- Application: NDA216078
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 December 2022
- Application: NDA211530
- Marketing authorisation holder: HOSPIRA
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 28 April 2023
- Application: ANDA204104
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA211001
- Marketing authorisation holder: MEITHEAL
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA214739
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA204230
- Marketing authorisation holder: APOTEX
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 7 June 2023
- Application: ANDA206554
- Marketing authorisation holder: NANG KUANG PHARM CO
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 3 July 2025
- Application: NDA219014
- Marketing authorisation holder: AVYXA HOLDINGS
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA210410
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — IV (INFUSION)
- Status: approved
FDA
- Application: ANDA209814
- Marketing authorisation holder: CELERITY PHARMS
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — IV (INFUSION)
- Status: approved
FDA
- Application: NDA215668
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA204771
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — IV (INFUSION)
- 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: 4,808
Most-reported reactions
- Off Label Use — 1,035 reports (21.53%)
- Pyrexia — 569 reports (11.83%)
- Disease Progression — 525 reports (10.92%)
- Drug Ineffective — 404 reports (8.4%)
- Covid-19 — 403 reports (8.38%)
- Product Use In Unapproved Indication — 402 reports (8.36%)
- Febrile Neutropenia — 381 reports (7.92%)
- Neutropenia — 373 reports (7.76%)
- Malignant Neoplasm Progression — 366 reports (7.61%)
- Pneumonia — 350 reports (7.28%)
BENDAMUSTINE HYDROCHLORIDE 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 BENDAMUSTINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 7 December 2015; FDA authorised it on 15 May 2018; FDA authorised it on 7 December 2022.
Who is the marketing authorisation holder for BENDAMUSTINE HYDROCHLORIDE in United States?
EAGLE PHARMS holds the US marketing authorisation.