Letrozole

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA090289 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Letrozole Tablets Are An Aromatase Inhibitor Indicated For: Adjuvant Treatment Of Postmenopausal Women With Hormone Receptor Positive Early Breast Cancer ( 1.1 ) Extended Adjuvant Treatment Of Postmenopausal Women With Early Breast Cancer Who Have Received Prior Standard Adjuvant Tamoxifen Therapy ( 1.2 ) First And Second-Line Treatment Of Postmenopausal Women With Hormone Receptor Positive Or Unknown Advanced Breast Cancer ( 1.3 ) 1.1 Adjuvant Treatment Of Early Breast Cancer Letrozole Tablets Are Indicated For The Adjuvant Treatment Of Postmenopausal Women With Hormone Receptor Positive Early Breast Cancer. 1.2 Extended Adjuvant Treatment Of Early Breast Cancer Letrozole Tablets Are Indicated For The Extended Adjuvant Treatment Of Early Breast Cancer In Postmenopausal Women, Who Have Received 5 Years Of Adjuvant Tamoxifen Therapy. The Effectiveness Of Letrozole Tablets In Extended Adjuvant Treatment Of Early Breast Cancer Is Based On An Analysis Of Disease-Free Survival In Patients Treated With Letrozole Tablets For A Median Of 60 Months [ See Clinical Studies ( 14.2 , 14.3 ) ]. 1.3 First And Second-Line Treatment Of Advanced Breast Cancer Letrozole Tablets Are Indicated For First-Line Treatment Of Postmenopausal Women With Hormone Receptor Positive Or Unknown, Locally Advanced Or Metastatic Breast Cancer. Letrozole Tablets Are Also Indicated For The Treatment Of Advanced Breast Cancer In Postmenopausal Women With Disease Progression Following Antiestrogen Therapy [ See Clinical Studies ( 14.4 , 14.5 ) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Letrozole LETROZOLE ZINC3778874

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