Application Nr Approved Date Route Status External Links
ANDA211031 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Exemestane Tablets Is An Aromatase Inhibitor Indicated For: Adjuvant Treatment Of Postmenopausal Women With Estrogen-Receptor Positive Early Breast Cancer Who Have Received Two To Three Years Of Tamoxifen And Are Switched To Exemestane Tablets For Completion Of A Total Of Five Consecutive Years Of Adjuvant Hormonal Therapy ( 14.1 ). Treatment Of Advanced Breast Cancer In Postmenopausal Women Whose Disease Has Progressed Following Tamoxifen Therapy ( 14.2 ). 1.1 Adjuvant Treatment Of Postmenopausal Women Exemestane Tablets Is Indicated For Adjuvant Treatment Of Postmenopausal Women With Estrogen-Receptor Positive Early Breast Cancer Who Have Received Two To Three Years Of Tamoxifen And Are Switched To Exemestane Tablets For Completion Of A Total Of Five Consecutive Years Of Adjuvant Hormonal Therapy [See Clinical Studies (14.1) ]. 1.2 Advanced Breast Cancer In Postmenopausal Women Exemestane Tablets Is Indicated For The Treatment Of Advanced Breast Cancer In Postmenopausal Women Whose Disease Has Progressed Following Tamoxifen Therapy [See Clinical Studies (14.2) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Exemestane EXEMESTANE ZINC3973334

Comments