FDA — authorised 22 September 2021
- Application: NDA022465
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
🇺🇸 PAZOPANIB in United States
FDA authorised PAZOPANIB on 22 September 2021 · 2,900 US adverse-event reports
Marketing authorisations
FDA — authorised 19 October 2023
- Application: ANDA217713
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 19 October 2023
- Application: ANDA215837
- Marketing authorisation holder: SUN PHARM
- Status: approved
FDA — authorised 19 October 2023
- Application: ANDA217517
- Marketing authorisation holder: TEVA PHARMS INC
- Status: approved
FDA — authorised 23 April 2024
- Application: ANDA218231
- Marketing authorisation holder: NOVUGEN
- Status: approved
FDA — authorised 4 December 2024
- Application: ANDA219034
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 4 September 2025
- Application: ANDA219922
- Marketing authorisation holder: TORRENT
- 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: 2,900
Most-reported reactions
- Malignant Neoplasm Progression — 520 reports (17.93%)
- Product Use In Unapproved Indication — 343 reports (11.83%)
- Diarrhoea — 320 reports (11.03%)
- Death — 305 reports (10.52%)
- Fatigue — 272 reports (9.38%)
- Disease Progression — 257 reports (8.86%)
- Drug Ineffective — 257 reports (8.86%)
- Nausea — 235 reports (8.1%)
- Off Label Use — 196 reports (6.76%)
- Vomiting — 195 reports (6.72%)
PAZOPANIB 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 PAZOPANIB approved in United States?
Yes. FDA authorised it on 22 September 2021; FDA authorised it on 19 October 2023; FDA authorised it on 19 October 2023.
Who is the marketing authorisation holder for PAZOPANIB in United States?
NOVARTIS holds the US marketing authorisation.