Anastrozole Tablets

FDA Drug Profile — Anastrozole

Drug Details

Generic Name
Anastrozole Tablets
Brand Names
Anastrozole
Application Number
ANDA206037
Sponsor
Yiling Pharmaceutical, Inc.
NDC Codes
4
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ANASTROZOLE

Indications and Usage

1 INDICATIONS AND USAGE Anastrozole is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( Error! Hyperlink reference not valid. ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( Error! Hyperlink reference not valid. ) • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole ( Error! Hyperlink reference not valid. ) 1.1 Adjuvant Treatment Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment Anastrozole is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. 1.3 Second-Line Treatment Anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole.