FDA — authorised 13 November 2013
- Application: NDA205552
- Marketing authorisation holder: PHARMACYCLICS LLC
- Local brand name: IMBRUVICA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Imbruvica in United States
FDA authorised Imbruvica on 13 November 2013 · 35,858 US adverse-event reports
Marketing authorisations
FDA — authorised 16 February 2018
- Application: NDA210563
- Marketing authorisation holder: PHARMACYCLICS LLC
- Status: supplemented
FDA — authorised 31 March 2021
- Application: ANDA211344
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: IBRUTINIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 August 2022
- Application: NDA217003
- Marketing authorisation holder: PHARMACYCLICS LLC
- Local brand name: IMBRUVICA
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA211350
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: IBRUTINIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA214498
- Marketing authorisation holder: ALVOGEN INC
- Local brand name: IBRUTINIB
- Indication: CAPSULE — ORAL
- 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: 35,858
Most-reported reactions
- Death — 7,885 reports (21.99%)
- Off Label Use — 4,903 reports (13.67%)
- Fatigue — 4,277 reports (11.93%)
- Diarrhoea — 3,575 reports (9.97%)
- Atrial Fibrillation — 2,882 reports (8.04%)
- Incorrect Dose Administered — 2,681 reports (7.48%)
- Contusion — 2,632 reports (7.34%)
- Pneumonia — 2,548 reports (7.11%)
- Fall — 2,326 reports (6.49%)
- Asthenia — 2,149 reports (5.99%)
Imbruvica 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 Imbruvica approved in United States?
Yes. FDA authorised it on 13 November 2013; FDA authorised it on 16 February 2018; FDA authorised it on 31 March 2021.
Who is the marketing authorisation holder for Imbruvica in United States?
PHARMACYCLICS LLC holds the US marketing authorisation.