FDA Should Lift Iressa Restrictions, Washington Legal Foundation Says
This article was originally published in The Pink Sheet Daily
Study data that aggregate the experience of many patients do not reflect the value of gefinitib in certain subgroups, WLF says in comments to the agency.
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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.
AstraZeneca communication to physicians/patients on Iressa survival data has been adequate, FDA Oncologic Drugs Advisory Committee says. FDA asks committee to discuss possibility of recommending Genentech/OSI Pharma’s Tarceva as alternative to Iressa in labeling, but committee resists.
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