exemestane
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, USP 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, USP 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, USP 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, USP are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies ( 14.2 )].