FDA — authorised 13 November 2013
- Marketing authorisation holder: PHARMACYCLICS INC
- Status: approved
🇺🇸 Imbruvica in United States
FDA authorised Imbruvica on 13 November 2013
Marketing authorisations
FDA — authorised 8 February 2016
- Application: NDA205552
- Marketing authorisation holder: PHARMACYCLICS LLC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 7 August 2020
- Application: NDA210563
- Marketing authorisation holder: PHARMACYCLICS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 22 February 2024
- Application: NDA217003
- Marketing authorisation holder: PHARMACYCLICS LLC
- Indication: Labeling
- Status: approved
The FDA approved Imbruvica, manufactured by Pharmacyclics LLC, on 22 February 2024. The approval was granted under the standard expedited pathway. The approved indication for Imbruvica is listed in its labelling, but the specific indication is not reported in the available data.
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 8 February 2016; FDA authorised it on 7 August 2020.
Who is the marketing authorisation holder for Imbruvica in United States?
PHARMACYCLICS INC holds the US marketing authorisation.