Novartis Femara
Executive Summary
Press release on Jan. 10 approval of letrozole hormone product for treatment of advanced breast cancer is cited by FDA letter for including data on Femara as pre-operative therapy. FDA reminds company Feb. 2 that Femara is not approved for pre-operative treatment to reduce tumor size before breast-conserving surgery and therefore the inclusion of the data "broadens the indication for Femara." FDA also asks company to cease distribution of journal ad