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 21 October 1999
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
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 26 July 2017
- Application: ANDA209208
- Marketing authorisation holder: UPSHER SMITH LABS
- 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
The FDA approved CIPLA's Aromasin for labeling on July 1, 2025. This approval was granted through a standard expedited pathway. Aromasin is a drug product, but the specific indication it is approved for is not specified in the provided information.
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 8 August 2019
- Application: ANDA208764
- Marketing authorisation holder: DR REDDYS LABS SA
- 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
The FDA approved EUGIA PHARMA's Aromasin for labeling on July 24, 2025. This approval was granted through the standard expedited pathway. Aromasin is a drug product, but the specific indication it is approved for is not reported in the provided information.
Aromasin 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 Aromasin approved in United States?
Yes. FDA authorised it on 21 October 1999; FDA authorised it on 21 October 1999; FDA authorised it on 1 April 2011.
Who is the marketing authorisation holder for Aromasin in United States?
PFIZER holds the US marketing authorisation.