FDA — authorised 19 October 2023
- Application: ANDA217517
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: PAZOPANIB HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 PAZOPANIB HYDROCHLORIDE in United States
FDA authorised PAZOPANIB HYDROCHLORIDE on 19 October 2023 · 114 US adverse-event reports
Marketing authorisations
FDA — authorised 19 October 2023
- Application: ANDA217713
- Marketing authorisation holder: APOTEX
- Local brand name: PAZOPANIB HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 2023
- Application: ANDA215837
- Marketing authorisation holder: SUN PHARM
- Local brand name: PAZOPANIB HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2024
- Application: ANDA218231
- Marketing authorisation holder: NOVUGEN
- Local brand name: PAZOPANIB HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2024
- Application: ANDA219034
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: PAZOPANIB HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2025
- Application: ANDA219922
- Marketing authorisation holder: TORRENT
- Local brand name: PAZOPANIB HYDROCHLORIDE
- Indication: TABLET — ORAL
- 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: 114
Most-reported reactions
- Malignant Neoplasm Progression — 19 reports (16.67%)
- Diarrhoea — 16 reports (14.04%)
- Drug Ineffective — 16 reports (14.04%)
- Hepatic Function Abnormal — 12 reports (10.53%)
- Rash — 10 reports (8.77%)
- Dyspnoea — 9 reports (7.89%)
- Arthralgia — 8 reports (7.02%)
- Ascites — 8 reports (7.02%)
- Off Label Use — 8 reports (7.02%)
- Urinary Tract Infection — 8 reports (7.02%)
PAZOPANIB 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 PAZOPANIB HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 19 October 2023; FDA authorised it on 19 October 2023; FDA authorised it on 19 October 2023.
Who is the marketing authorisation holder for PAZOPANIB HYDROCHLORIDE in United States?
TEVA PHARMS INC holds the US marketing authorisation.