FDA — authorised 14 November 1960
- Status: approved
🇺🇸 Glucagen in United States
FDA authorised Glucagen on 14 November 1960
Marketing authorisations
FDA — authorised 22 June 1998
- Application: NDA020918
- Marketing authorisation holder: NOVO NORDISK
- Local brand name: GLUCAGEN
- Indication: POWDER — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 8 May 2015
- Application: NDA201849
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 7 April 2020
- Application: NDA212097
- Marketing authorisation holder: XERIS
- Indication: Labeling
- Status: approved
FDA — authorised 27 October 2020
- Application: NDA210134
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 28 December 2020
- Application: ANDA208086
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Status: approved
FDA — authorised 15 September 2025
- Application: ANDA218813
- Marketing authorisation holder: CIPLA
- Status: approved
Glucagen 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 Glucagen approved in United States?
Yes. FDA authorised it on 14 November 1960; FDA authorised it on 22 June 1998; FDA authorised it on 8 May 2015.
Who is the marketing authorisation holder for Glucagen in United States?
Xeris is the originator. The local marketing authorisation holder may differ — check the official source linked above.