Application Nr Approved Date Route Status External Links
NDA021344 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Monotherapy Faslodex Is Indicated For The Treatment Of: • Hormone Receptor (hr)-Positive, Human Epidermal Growth Factor Receptor 2 (her2)-Negative Advanced Breast Cancer In Postmenopausal Women Not Previously Treated With Endocrine Therapy, Or • Hr-Positive Advanced Breast Cancer In Postmenopausal Women With Disease Progression Following Endocrine Therapy. Combination Therapy Faslodex Is Indicated For The Treatment Of: • Hr-Positive, Her2-Negative Advanced Or Metastatic Breast Cancer In Postmenopausal Women In Combination With Ribociclib As Initial Endocrine Based Therapy Or Following Disease Progression On Endocrine Therapy. • Hr-Positive, Her2-Negative Advanced Or Metastatic Breast Cancer In Combination With Palbociclib Or Abemaciclib In Women With Disease Progression After Endocrine Therapy. Faslodex Is An Estrogen Receptor Antagonist Indicated For The Treatment Of: • Hormone Receptor (hr)-Positive, Human Epidermal Growth Factor Receptor 2 (her2)-Negative Advanced Breast Cancer In Postmenopausal Women Not Previously Treated With Endocrine Therapy. (1) • Hr-Positive Advanced Breast Cancer In Postmenopausal Women With Disease Progression Following Endocrine Therapy. (1) • Hr-Positive, Her2-Negative Advanced Or Metastatic Breast Cancer In Postmenopausal Women In Combination With Ribociclib, As Initial Endocrine Based Therapy Or Following Disease Progression On Endocrine Therapy. (1) • Hr-Positive, Her2-Negative Advanced Or Metastatic Breast Cancer In Combination With Palbociclib Or Abemaciclib In Women With Disease Progression After Endocrine Therapy. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fulvestrant FULVESTRANT ZINC3995809

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