FDA — authorised 31 July 2003
- Marketing authorisation holder: ACTELION PHARMS LTD
- Status: approved
🇺🇸 Zavesca in United States
FDA authorised Zavesca on 31 July 2003
Marketing authorisations
FDA — authorised 31 July 2003
- Application: NDA021348
- Marketing authorisation holder: ACTELION
- Local brand name: ZAVESCA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA208342
- Marketing authorisation holder: ANI PHARMS
- Local brand name: MIGLUSTAT
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 August 2020
- Application: ANDA209821
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Local brand name: YARGESA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 February 2022
- Application: ANDA209325
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MIGLUSTAT
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 September 2023
- Application: NDA215211
- Marketing authorisation holder: AMICUS THERAP US
- Local brand name: OPFOLDA
- Indication: CAPSULE — ORAL
- Status: approved
Zavesca in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Zavesca approved in United States?
Yes. FDA authorised it on 31 July 2003; FDA authorised it on 31 July 2003; FDA authorised it on 17 April 2018.
Who is the marketing authorisation holder for Zavesca in United States?
ACTELION PHARMS LTD holds the US marketing authorisation.