FDA — authorised 26 June 2020
- Application: NDA208232
- Marketing authorisation holder: CHIESI
- Local brand name: MYCAPSSA
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised octreotide capsules on 26 June 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 26 June 2020.
CHIESI holds the US marketing authorisation.