🇺🇸 Ocrevus in United States

FDA authorised Ocrevus on 28 March 2017 · 35,820 US adverse-event reports

Marketing authorisations

FDA — authorised 28 March 2017

  • Application: BLA761053
  • Marketing authorisation holder: GENENTECH INC
  • Status: supplemented

FDA — authorised 13 September 2024

  • Application: BLA761371
  • Marketing authorisation holder: GENENTECH INC
  • 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.

Most-reported reactions

  1. Covid-19 — 9,567 reports (26.71%)
  2. Fatigue — 5,550 reports (15.49%)
  3. Urinary Tract Infection — 3,314 reports (9.25%)
  4. Headache — 2,889 reports (8.07%)
  5. Multiple Sclerosis — 2,682 reports (7.49%)
  6. Gait Disturbance — 2,426 reports (6.77%)
  7. Asthenia — 2,408 reports (6.72%)
  8. Multiple Sclerosis Relapse — 2,404 reports (6.71%)
  9. Fall — 2,301 reports (6.42%)
  10. Pain — 2,279 reports (6.36%)

Source database →

Ocrevus in other countries

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

Other Neuroscience approved in United States

Frequently asked questions

Is Ocrevus approved in United States?

Yes. FDA authorised it on 28 March 2017; FDA authorised it on 13 September 2024; FDA has authorised it.

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

GENENTECH INC holds the US marketing authorisation.