FDA makes it official: AstraZeneca's Iressa, Sanofi's Oforta NDAs withdrawn
This article was originally published in Scrip
Executive Summary
More than a year after US regulators let the cat out of the bag at a 8 February 2011 public meeting that AstraZeneca planned to withdraw its new drug application (NDA) for Iressa (gefitinib, ZD1839), an epidermal growth factor receptor tyrosine kinase inhibitor, as a treatment for non-small-cell lung cancer (NSCLC), the FDA made it official, withdrawing approval of the NDA, according to a notice published in the US Federal Register(scripintelligence, 9 February 2011).