FDA — authorised 9 June 2009
- Application: ANDA090270
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 MELPHALAN HYDROCHLORIDE in United States
FDA authorised MELPHALAN HYDROCHLORIDE on 9 June 2009 · 1,143 US adverse-event reports
Marketing authorisations
FDA — authorised 27 October 2009
- Application: ANDA090299
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 October 2010
- Application: ANDA090303
- Marketing authorisation holder: HIKMA
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2016
- Application: ANDA204773
- Marketing authorisation holder: PH HEALTH
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 2016
- Application: ANDA206018
- Marketing authorisation holder: ACTAVIS LLC
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2017
- Application: ANDA203655
- Marketing authorisation holder: DR REDDYS
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA203393
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 May 2019
- Application: ANDA204817
- Marketing authorisation holder: ALMAJECT
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2019
- Application: ANDA209826
- Marketing authorisation holder: GLAND
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 September 2019
- Application: ANDA211463
- Marketing authorisation holder: ARTHUR GRP
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 March 2020
- Application: ANDA209323
- Marketing authorisation holder: ACTAVIS LLC
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA209197
- Marketing authorisation holder: BPI LABS
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2021
- Application: ANDA212960
- Marketing authorisation holder: MEITHEAL
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 August 2023
- Application: NDA201848
- Marketing authorisation holder: DELCATH SYSTEMS INC
- Local brand name: HEPZATO
- Indication: POWDER — INTRA-ARTERIAL
- Status: approved
FDA — authorised 18 August 2023
- Application: NDA217110
- Marketing authorisation holder: APOTEX
- Local brand name: IVRA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 May 2024
- Application: ANDA215024
- Marketing authorisation holder: HETERO LABS
- Local brand name: MELPHALAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 October 2024
- Application: ANDA206523
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: MELPHALAN HYDROCHLORIDE
- 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: 1,143
Most-reported reactions
- Pyrexia — 141 reports (12.34%)
- Mucosal Inflammation — 134 reports (11.72%)
- Neutropenia — 120 reports (10.5%)
- Febrile Neutropenia — 116 reports (10.15%)
- Diarrhoea — 111 reports (9.71%)
- Thrombocytopenia — 107 reports (9.36%)
- Pneumonia — 106 reports (9.27%)
- Sepsis — 106 reports (9.27%)
- Acute Graft Versus Host Disease — 104 reports (9.1%)
- Drug Ineffective — 98 reports (8.57%)
MELPHALAN 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 MELPHALAN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 9 June 2009; FDA authorised it on 27 October 2009; FDA authorised it on 28 October 2010.
Who is the marketing authorisation holder for MELPHALAN HYDROCHLORIDE in United States?
MYLAN INSTITUTIONAL holds the US marketing authorisation.