FDA Approval Activities for this Drug
Femara (letrozole) Tablets, 2.5 mg, Novartis NDA 20-726/S8 1/17/03 1/23/03 1/23/03
Femara (letrozole) Tablets, Novartis NDA 20-726/S-006 1/10/01 1/16/01 1/16/01 7/12/01
Femara (letrozole) Tablets, Novartis NDA 20-726/S-005 2/26/03 3/10/03 3/11/03
Femara Indications: First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. | Femara (Letrozole) Tablets, Novartis Pharma, New or Modified Indication | Femara (Letrozole) Tablets, Novartis Pharma, New or Modified Indication | Femara (letrozole) Tablets, Novartis Pharma, Labeling Revision | Femara (letrozole) Tablets, Novartis Pharma, Labeling Revision | Letrozole Tablets, Mylan Pharma, Tentative Approval | Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision