Fulvestrant

Product manufactured by Sandoz Inc

Application Nr Approved Date Route Status External Links
ANDA205935 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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 . Fulvestrant 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

Comments