🇺🇸 PONATINIB HYDROCHLORIDE in United States

FDA authorised PONATINIB HYDROCHLORIDE on 14 July 2023 · 60 US adverse-event reports

Marketing authorisations

FDA — authorised 14 July 2023

  • Application: ANDA215893
  • Marketing authorisation holder: APOTEX
  • Local brand name: PONATINIB HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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.

Most-reported reactions

  1. Febrile Neutropenia — 9 reports (15%)
  2. Pyrexia — 8 reports (13.33%)
  3. Diarrhoea — 7 reports (11.67%)
  4. Nausea — 7 reports (11.67%)
  5. Abdominal Pain — 6 reports (10%)
  6. Headache — 5 reports (8.33%)
  7. Platelet Count Decreased — 5 reports (8.33%)
  8. Syncope — 5 reports (8.33%)
  9. Atrial Fibrillation — 4 reports (6.67%)
  10. Chills — 4 reports (6.67%)

Source database →

PONATINIB 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 PONATINIB HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 14 July 2023; FDA has authorised it.

Who is the marketing authorisation holder for PONATINIB HYDROCHLORIDE in United States?

APOTEX holds the US marketing authorisation.