FDA — authorised 1 August 2014
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Jardiance in United States
FDA authorised Jardiance on 1 August 2014
Marketing authorisations
FDA — authorised 4 December 2015
- Application: NDA206111
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 13 December 2017
- Application: NDA206073
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 24 January 2020
- Application: NDA204629
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 30 October 2023
- Application: NDA212614
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 7 March 2025
- Application: NDA208658
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Efficacy
- Status: approved
The FDA approved Jardiance, a medication developed by Boehringer Ingelheim, on 7 March 2025. The approval was granted through a standard expedited pathway, with the application number NDA208658. The approved indication for Jardiance is its efficacy, although the specific indication is not specified in the available information.
Jardiance 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 Jardiance approved in United States?
Yes. FDA authorised it on 1 August 2014; FDA authorised it on 4 December 2015; FDA authorised it on 13 December 2017.
Who is the marketing authorisation holder for Jardiance in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.