EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for letrozole tablets USP, 2.5 mg. Aurobindo’s letrozole tablets are an AB-rated generic equivalent to the reference listed drug, Novartis’ Femara.
Letrozole is an aromatase inhibitor indicated for:
- Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
- Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy.
- First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer.
