letrozole 2.5 MG Oral Tablet
1 INDICATIONS AND USAGE Letrozole tablet is 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 )].
Accord Healthcare, Inc.
ROUND YELLOW LT
LT ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Packaged in HDPE bottles and unit dose blister package. 2.5 mg tablets – yellow round, biconvex, film coated tablets imprinted with 'LT' on one side and plain on other side. Bottles of 30 tablets with a child-resistant closure ...................................................................................NDC 16729-034-10 Bottles of 90 tablets with a child-resistant closure ...................................................................................NDC 16729-034-15 Bottles of 100 tablets with a child-resistant closure..................................................................................NDC 16729-034-01 Bottles of 500 tablets.................................................................................................................NDC 16729-034-16 Bottles of 1000 tablets................................................................................................................NDC 16729-034-17 Unit dose blister package 100 (10x10)...................................................................................................NDC 16729-034-43 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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