FDA — authorised 22 March 2021
- Marketing authorisation holder: ZEALAND PHARMA AS
- Status: approved
🇺🇸 Zegalogue in United States
FDA authorised Zegalogue on 22 March 2021
Marketing authorisations
FDA — authorised 22 March 2021
- Application: NDA214231
- Marketing authorisation holder: ZEALAND PHARMA
- Local brand name: ZEGALOGUE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Zegalogue 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 Zegalogue approved in United States?
Yes. FDA authorised it on 22 March 2021; FDA authorised it on 22 March 2021.
Who is the marketing authorisation holder for Zegalogue in United States?
ZEALAND PHARMA AS holds the US marketing authorisation.