Skip to main content

Faslodex FDA Approval History

FDA Approved: Yes (First approved April 25, 2002)
Brand name: Faslodex
Generic name: fulvestrant
Dosage form: Injection
Company: AstraZeneca
Treatment for: Breast Cancer

Faslodex (fulvestrant) is an estrogen receptor antagonist indicated for the treatment of hormone receptor positive metastatic breast cancer.

Development timeline for Faslodex

Nov 15, 2017Approval Faslodex (fulvestrant) Receives FDA Approval for the Treatment of Advanced Breast Cancer in Combination with Abemaciclib
Aug 28, 2017Approval Faslodex (fulvestrant) Receives FDA Approval as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer
Sep 13, 2010Approval FDA Approves New Dosing for Faslodex (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
Apr 25, 2002Approval AstraZeneca Receives FDA Approval for Faslodex (fulvestrant): A New Type of Breast Cancer Treatment Effective In Tamoxifen-Resistant Breast Cancer

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.