FDA — authorised 16 August 2023
- Application: NDA215559
- Marketing authorisation holder: IPSEN
- Local brand name: SOHONOS
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Sohonos on 16 August 2023
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 16 August 2023.
IPSEN holds the US marketing authorisation.