Federal Register Notice: FDA has determined the regulatory review period for AstraZeneca’s Iressa is 1,967 days for extending a patent which claims that human drug product. Iressa (gefitinib) is indicated as monotherapy for the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies who are benefiting or have benefited from Iressa. To view this notice, click here.