FDA — authorised 25 April 2002
- Application: NDA021344
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: FASLODEX
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
🇺🇸 Faslodex in United States
FDA authorised Faslodex on 25 April 2002
Marketing authorisations
FDA — authorised 4 March 2019
- Application: ANDA210044
- Marketing authorisation holder: AMNEAL
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 14 May 2019
- Application: ANDA205935
- Marketing authorisation holder: SANDOZ
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 20 May 2019
- Application: NDA210326
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 19 August 2019
- Application: NDA210063
- Marketing authorisation holder: AVYXA HOLDINGS
- Local brand name: CLIGAVYX
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 22 August 2019
- Application: ANDA207754
- Marketing authorisation holder: GLENMARK PHARMS
- Status: approved
FDA — authorised 22 August 2019
- Application: ANDA205871
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 21 November 2019
- Application: ANDA209714
- Marketing authorisation holder: HBT LABS INC
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 7 February 2020
- Application: ANDA211422
- Marketing authorisation holder: CHIA TAI TIANQING
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 7 August 2020
- Application: ANDA209246
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 17 November 2020
- Application: ANDA211689
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 11 June 2021
- Application: ANDA211730
- Marketing authorisation holder: APOTEX
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 29 July 2021
- Application: ANDA215234
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 13 August 2021
- Application: ANDA213553
- Marketing authorisation holder: XIROMED
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 22 December 2022
- Application: ANDA215077
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 30 June 2023
- Application: ANDA215169
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: FULVESTRANT
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 17 September 2025
- Application: ANDA214682
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Indication: Labeling
- Status: approved
The FDA approved Faslodex, a drug for the treatment of hormone receptor-positive metastatic breast cancer, on 17 September 2025. The approval was granted to Jiangsu Hansoh Pharm, the marketing authorisation holder. Faslodex is a standard application under the expedited pathway.
Faslodex 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 Faslodex approved in United States?
Yes. FDA authorised it on 25 April 2002; FDA authorised it on 4 March 2019; FDA authorised it on 14 May 2019.
Who is the marketing authorisation holder for Faslodex in United States?
ASTRAZENECA holds the US marketing authorisation.