FDA — authorised 28 June 2010
- Application: ANDA090568
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
🇺🇸 Arimidex in United States
FDA authorised Arimidex on 28 June 2010
Marketing authorisations
FDA — authorised 18 April 2011
- Application: NDA020541
- Marketing authorisation holder: ANI PHARMS
- Indication: Efficacy
- Status: approved
FDA — authorised 18 February 2025
- Application: ANDA078921
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Indication: Labeling
- Status: approved
The FDA approved Arimidex, an anastrozole-containing product, for marketing in the United States on 18 February 2025. The marketing authorisation holder is ZYDUS PHARMS USA INC. The approval was granted through the standard expedited pathway. Arimidex is indicated for use in the treatment of breast cancer.
FDA — authorised 15 July 2025
- Application: ANDA079220
- Marketing authorisation holder: NATCO PHARMA LTD
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to NATCO Pharma Ltd for Arimidex on 15 July 2025. This approval was made under the standard expedited pathway. Arimidex is indicated for use in labelling, but the specific local brand name is not reported.
FDA — authorised 24 October 2025
- Application: ANDA212434
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Arimidex for labeling indications on October 24, 2025. This approval was granted to EUGIA PHARMA under application number ANDA212434. Arimidex is a medication used to treat various conditions, but the specific labeling indications are not specified in the available data.
Arimidex 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 Arimidex approved in United States?
Yes. FDA authorised it on 28 June 2010; FDA authorised it on 18 April 2011; FDA authorised it on 18 February 2025.
Who is the marketing authorisation holder for Arimidex in United States?
ACCORD HLTHCARE holds the US marketing authorisation.