FDA — authorised 18 December 2020
- Application: NDA214621
- Marketing authorisation holder: SUMITOMO PHARMA AM
- Local brand name: ORGOVYX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Orgovyx in United States
FDA authorised Orgovyx on 18 December 2020
Marketing authorisations
FDA — authorised 27 August 2025
- Application: NDA214846
- Marketing authorisation holder: SUMITOMO PHARMA AM
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to Orgovyx on 27 August 2025. This decision was made following a standard review of the application. Orgovyx is a product of Sumitomo Pharma America, Inc. and is intended for its approved indication as stated in the labelling.
Orgovyx 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 Orgovyx approved in United States?
Yes. FDA authorised it on 18 December 2020; FDA authorised it on 27 August 2025.
Who is the marketing authorisation holder for Orgovyx in United States?
SUMITOMO PHARMA AM holds the US marketing authorisation.