exemestane

FDA Drug Profile — EXEMESTANE, Aromasin

exemestane is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including EXEMESTANE, Aromasin. Available dosage form: tablet.

Drug Details

Generic Name
exemestane
Brand Names
EXEMESTANE, Aromasin
Application Number
ANDA210323
Sponsor
Cipla USA Inc.
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
EXEMESTANE

Indications and Usage

1 INDICATIONS AND USAGE Exemestane is an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1) ]. 1.2 Advanced Breast Cancer in Postmenopausal Women Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ].