Roxane announces FDA approval for Anastrozole Tablets ANDA

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the U.S. Food and Drug Administration.  The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories' Anastrozole Tablets are AB rated to ARIMIDEX® (anastrozole) tablets.  Annual sales of ARIMIDEX® are approximately $916.8 Million(1). ARIMIDEX® (anastrozole) is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer; First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer; treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.