FDA — authorised 9 December 1997
- Marketing authorisation holder: LILLY
- Status: approved
🇺🇸 Evista in United States
FDA authorised Evista on 9 December 1997
Marketing authorisations
FDA — authorised 9 December 1997
- Application: NDA020815
- Marketing authorisation holder: LILLY
- Local brand name: EVISTA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2015
- Application: ANDA204310
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 8 April 2016
- Application: ANDA208206
- Marketing authorisation holder: AMNEAL PHARMS
- Status: approved
FDA — authorised 18 August 2020
- Application: ANDA211324
- Marketing authorisation holder: CADILA PHARMS LTD
- Status: approved
FDA — authorised 27 August 2024
- Application: ANDA078193
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
The FDA approved Evista for labeling indication on 27 August 2024. This approval was granted to TEVA PHARMS USA under standard expedited pathway. The application number for this approval is ANDA078193.
Evista in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Evista approved in United States?
Yes. FDA authorised it on 9 December 1997; FDA authorised it on 9 December 1997; FDA authorised it on 28 August 2015.
Who is the marketing authorisation holder for Evista in United States?
LILLY holds the US marketing authorisation.