Fulvestrant

Product manufactured by Hbt Labs, Inc.

Application Nr Approved Date Route Status External Links
ANDA209714 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fulvestrant Injection 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 ) Monotherapy Fulvestrant Injection 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 Fulvestrant Injection 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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