FDA — authorised 6 March 2020
- Application: NDA212801
- Marketing authorisation holder: RECORDATI RARE
- Local brand name: ISTURISA
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Osilodrostat (Isturisa) on 6 March 2020
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 6 March 2020.
RECORDATI RARE holds the US marketing authorisation.