anastrozole

FDA Drug Profile

Drug Details

Generic Name
anastrozole
Brand Names
N/A
Application Number
Sponsor
SUN PHARMACEUTICAL INDUSTRIES, INC.
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
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.