AstraZeneca's Iressa Use Narrowed: No New Commercial Patients
This article was originally published in The Pink Sheet Daily
Revised labeling for the oncologic restricts use to patients who have already received the drug and benefited from it, as well as certain clinical trial participants. Beginning Sept. 15, Iressa patients will have to refill prescriptions through a single mail order pharmacy.
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Drug Review Profile of the second life of AstraZeneca’s Iressa shows how FDA adapts to imperfect but improving information without putting undue burden on sponsors – and how the agency recently applied a similar iterative approach to another EGFR inhibitor, Astellas and Genentech’s Tarceva.
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