FDA — authorised 21 October 2016
- Application: BLA761046
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: ZINPLAVA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Zinplava on 21 October 2016
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 21 October 2016; FDA has authorised it.
MERCK SHARP DOHME holds the US marketing authorisation.