Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA makes it official: AstraZeneca's Iressa, Sanofi's Oforta NDAs withdrawn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).



Related Companies




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts