🇺🇸 Campath in United States

FDA authorised Campath on 7 May 2001 · 1,622 US adverse-event reports

Marketing authorisations

FDA — authorised 7 May 2001

  • Application: BLA103948
  • Marketing authorisation holder: GENZYME
  • Local brand name: CAMPATH
  • Indication: VIAL — INTRAVENOUS
  • Status: approved

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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. Pyrexia — 286 reports (17.63%)
  2. Cytomegalovirus Infection — 222 reports (13.69%)
  3. Death — 210 reports (12.95%)
  4. Off Label Use — 204 reports (12.58%)
  5. Neutropenia — 136 reports (8.38%)
  6. Pneumonia — 130 reports (8.01%)
  7. Pancytopenia — 119 reports (7.34%)
  8. Graft Versus Host Disease — 107 reports (6.6%)
  9. Drug Ineffective — 105 reports (6.47%)
  10. Febrile Neutropenia — 103 reports (6.35%)

Source database →

Campath in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Campath approved in United States?

Yes. FDA authorised it on 7 May 2001; FDA has authorised it.

Who is the marketing authorisation holder for Campath in United States?

GENZYME holds the US marketing authorisation.