🇺🇸 JAK Inhibitor in United States

4 US adverse-event reports

Marketing authorisations

FDA

  • Application: ANDA220375
  • Marketing authorisation holder: TORRENT PHARMACEUTICALS LTD
  • Local brand name: RUXOLITINIB
  • Indication: TABLET
  • Status: approved

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FDA

  • Application: NDA219660
  • Marketing authorisation holder: APOTEX
  • Local brand name: Ruxolitinib
  • Indication: TABLET — ORAL
  • Status: approved

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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. Chills — 1 report (25%)
  2. Gastric Ulcer — 1 report (25%)
  3. Gastrointestinal Haemorrhage — 1 report (25%)
  4. Pyrexia — 1 report (25%)

Source database →

Other Oncology, Immunology approved in United States

Frequently asked questions

Is JAK Inhibitor approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for JAK Inhibitor in United States?

TORRENT PHARMACEUTICALS LTD holds the US marketing authorisation.