FDA — authorised 19 November 1948
- Status: approved
🇺🇸 Epipen in United States
FDA authorised Epipen on 19 November 1948
Marketing authorisations
FDA — authorised 30 March 2006
- Application: NDA020971
- Marketing authorisation holder: DEPROCO
- Indication: Labeling
- Status: approved
FDA — authorised 30 August 2011
- Application: ANDA078959
- Marketing authorisation holder: SEPTODONT INC
- Status: approved
FDA — authorised 23 April 2021
- Application: ANDA090589
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 20 November 2024
- Application: ANDA213708
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 28 February 2025
- Application: NDA218475
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved a new formulation of Epipen, a medication used to treat severe allergic reactions, on February 28, 2025. The approval was granted to Baxter Healthcare Corp under the standard expedited pathway. This approval is classified as a Type 5 new formulation or new manufacturer approval.
Epipen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Epipen approved in United States?
Yes. FDA authorised it on 19 November 1948; FDA authorised it on 30 March 2006; FDA authorised it on 30 August 2011.
Who is the marketing authorisation holder for Epipen in United States?
Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.