AstraZeneca Withdraws Iressa Accelerated Approval NDA; Rules out Refiling with PGx Data

Feb 09, 2011

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AstraZeneca announced earlier this month that it will not seek approval from the US Food and Drug Administration for its EGFR tyrosine kinase inhibitor Iressa as a treatment for non-small cell lung cancer.

"AstraZeneca does not plan to pursue approval for Iressa in the US," the company said in a statement. Furthermore, AstraZeneca has informed the FDA that it will be withdrawing its accelerated approval new drug application for Iressa as of Sept. 30.

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