FDA — authorised 30 January 2012
- Application: NDA203388
- Marketing authorisation holder: GENENTECH
- Local brand name: ERIVEDGE
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Erivedge on 30 January 2012
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 30 January 2012.
GENENTECH holds the US marketing authorisation.