FDA — authorised 28 March 2017
- Application: BLA761053
- Marketing authorisation holder: GENENTECH INC
- Local brand name: OCREVUS
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ocrevus in United States
FDA authorised Ocrevus on 28 March 2017
Marketing authorisations
FDA — authorised 18 August 2025
- Application: BLA761371
- Marketing authorisation holder: GENENTECH INC
- Indication: Labeling
- Status: approved
The FDA approved Ocrevus, a medication developed by GENENTECH INC, for its approved indication on 18 August 2025. The application number for this approval is BLA761371. This approval was granted through the standard expedited pathway. The marketing authorisation holder for Ocrevus is GENENTECH INC, and the local brand name is not reported.
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 18 August 2025.
Who is the marketing authorisation holder for Ocrevus in United States?
GENENTECH INC holds the US marketing authorisation.