FDA — authorised 15 August 2019
- Marketing authorisation holder: GENENTECH INC
- Status: approved
🇺🇸 Rozlytrek in United States
FDA authorised Rozlytrek on 15 August 2019
Marketing authorisations
FDA — authorised 15 August 2019
- Application: NDA212725
- Marketing authorisation holder: GENENTECH INC
- Local brand name: ROZLYTREK
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 August 2019
- Application: NDA212726
- Marketing authorisation holder: GENENTECH INC
- Local brand name: ROZLYTREK
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 October 2023
- Application: NDA218550
- Marketing authorisation holder: GENENTECH INC
- Local brand name: ROZLYTREK
- Indication: PELLETS — ORAL
- Status: approved
Rozlytrek 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 Rozlytrek approved in United States?
Yes. FDA authorised it on 15 August 2019; FDA authorised it on 15 August 2019; FDA authorised it on 15 August 2019.
Who is the marketing authorisation holder for Rozlytrek in United States?
GENENTECH INC holds the US marketing authorisation.