ZENECA ARIMIDEX (ANASTROZOLE) LAUNCH SET FOR MID-JANUARY; FDA APPROVES ORAL TABLET FOR POST-TAMOXIFEN TREATMENT OF ADVANCED BREAST CANCER DEC. 27

Executive Summary

Zeneca will launch Arimidex (anastrozole) in mid-January after gaining FDA approval to market the drug Dec. 27. The 1 mg once-daily anastrozole tablets were approved nine months after the March 28 NDA submission (20-541) for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Arimidex received a "1S" review, meaning a standard review of a drug that is substantially equivalent to existing therapies and is a new molecular entity. FDA's approval comes close on the heels of approval in the U.K., where the product was approved in September.