FDA — authorised 12 February 2021
- Application: NDA214200
- Marketing authorisation holder: PHARMACOSMOS
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA authorised TRILACICLIB on 12 February 2021
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 February 2021.
PHARMACOSMOS holds the US marketing authorisation.