FDA — authorised 9 April 1987
- Application: ANDA089395
- Marketing authorisation holder: HIKMA
- Local brand name: VINBLASTINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 VINBLASTINE SULFATE in United States
FDA authorised VINBLASTINE SULFATE on 9 April 1987 · 1,039 US adverse-event reports
Marketing authorisations
FDA — authorised 29 April 1987
- Application: ANDA089515
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: supplemented
FDA — authorised 18 August 1987
- Application: ANDA089565
- Marketing authorisation holder: HOSPIRA
- Local brand name: VINBLASTINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089011
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: VINBLASTINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089311
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: VINBLASTINE SULFATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA089365
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: VINBLASTINE SULFATE
- Indication: Injectable — Injection
- 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: 1,039
Most-reported reactions
- Febrile Neutropenia — 188 reports (18.09%)
- Neutropenia — 151 reports (14.53%)
- Pyrexia — 132 reports (12.7%)
- Nausea — 93 reports (8.95%)
- Vomiting — 85 reports (8.18%)
- Neuropathy Peripheral — 82 reports (7.89%)
- Off Label Use — 79 reports (7.6%)
- Pulmonary Toxicity — 79 reports (7.6%)
- Neutrophil Count Decreased — 76 reports (7.31%)
- Anaemia — 74 reports (7.12%)
VINBLASTINE SULFATE 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 VINBLASTINE SULFATE approved in United States?
Yes. FDA authorised it on 9 April 1987; FDA authorised it on 29 April 1987; FDA authorised it on 18 August 1987.
Who is the marketing authorisation holder for VINBLASTINE SULFATE in United States?
HIKMA holds the US marketing authorisation.