FDA — authorised 13 May 2011
- Application: NDA202258
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: VICTRELIS
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Cross-Over Boceprevir Treatment on 13 May 2011
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 13 May 2011.
MERCK SHARP DOHME holds the US marketing authorisation.