FDA — authorised 21 October 1999
- Application: NDA020753
- Marketing authorisation holder: PFIZER
- Local brand name: AROMASIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Aromasin in United States
FDA authorised Aromasin on 21 October 1999
Marketing authorisations
FDA — authorised 1 April 2011
- Application: ANDA077431
- Marketing authorisation holder: HIKMA
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 2014
- Application: ANDA200898
- Marketing authorisation holder: ALVOGEN
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2017
- Application: ANDA203315
- Marketing authorisation holder: RISING
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2018
- Application: ANDA210323
- Marketing authorisation holder: CIPLA
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2018
- Application: ANDA202602
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 2018
- Application: ANDA206421
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 February 2019
- Application: ANDA211031
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 2020
- Application: ANDA213547
- Marketing authorisation holder: QILU
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2022
- Application: ANDA216454
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: EXEMESTANE
- Indication: TABLET — ORAL
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is Aromasin approved in United States?
Yes. FDA authorised it on 21 October 1999; FDA authorised it on 1 April 2011; FDA authorised it on 28 July 2014.
Who is the marketing authorisation holder for Aromasin in United States?
PFIZER holds the US marketing authorisation.