FDA — authorised 27 September 2002
- Marketing authorisation holder: GD SEARLE LLC
- Status: approved
🇺🇸 Inspra in United States
FDA authorised Inspra on 27 September 2002
Marketing authorisations
FDA — authorised 27 September 2002
- Application: NDA021437
- Marketing authorisation holder: UPJOHN
- Local brand name: INSPRA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2008
- Application: ANDA078510
- Marketing authorisation holder: SANDOZ
- Local brand name: EPLERENONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2017
- Application: ANDA206922
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 14 September 2018
- Application: ANDA208283
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: EPLERENONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2021
- Application: ANDA207842
- Marketing authorisation holder: WESTMINSTER PHARMS
- Local brand name: EPLERENONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 2023
- Application: ANDA213812
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 4 December 2025
- Application: ANDA214663
- Marketing authorisation holder: RISING
- Indication: Labeling
- Status: approved
The FDA approved Inspra for its approved labeling on December 4, 2025. The marketing authorization holder is RISING. Inspra was approved through a standard expedited pathway.
Inspra 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 Inspra approved in United States?
Yes. FDA authorised it on 27 September 2002; FDA authorised it on 27 September 2002; FDA authorised it on 1 August 2008.
Who is the marketing authorisation holder for Inspra in United States?
GD SEARLE LLC holds the US marketing authorisation.