Lannett Company announced it has received approval from the Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Letrozole Tablets, the generic version of Novartis‘ Femara.
Femara is an aromatase inhibitor indicated as an adjuvant treatment of hormone receptor positive early breast cancer; extended adjuvant treatment of early breast cancer after five years of adjuvant tamoxifen therapy; first-line treatment of hormone receptor positive or unknown, locally advanced, or metastatic breast cancer; and for the treatment of advanced breast cancer with disease progression following antiestrogen therapy in postmenopausal women.
Letrozole Tablets will be available as a 2.5mg strength. Lannett expects to begin shipping the product in the coming months.
For more information visit Lannett.com.