Rx Item-Letrozole 2.5Mg Tab 30 By Accord Healthcare Gen Femara

LETROZOLE- letrozole tablet, film coated
Teva Pharmaceuticals USA Inc

1 INDICATIONS AND USAGE

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)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose
The recommended dose of letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals.

2.2 Use in Adjuvant Treatment of Early Breast Cancer
In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy. Treatment should be discontinued at relapse [see Clinical Studies (14.1) ].

RX ITEM-Letrozole 2.5Mg Tab 30 By Accord
NDC 16729-0034-10 UPC/GTIN No.3-16729-03410-4 Mfg.Part No.3410

Letrozole 2.5Mg Tab 30 By Accord Healthc
BRAND: LETROZOLE NDC: 16729-0034-10,16729003410 UPC: 3-16729-03410-4,316729034104 Accord Healthcare Inc.

LETROZOLE ORAL TABLET 2.5
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Drug info from Dailymed
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