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Case Detail


In re Restriction on Lung Cancer Drug
(Regulatory Proceeding)
On July 25, 2005, WLF filed comments with the Food and Drug Administration asking the agency to withdraw or modify its order for the restrictive labeling of the lung cancer drug Iressa. WLF's comments were joined by three patient groups, the Abigail Alliance for Better Access to Developmental Drugs, the Lorenzen Cancer Foundation, and the Lung Cancer Alliance. FDA's action effectively limits the use of Iressa in the United States to the approximately 4,000 patients already being treated with it. WLF's comments argued that this limitation on the availability of Iressa is unjustified and will harm lung cancer patients in the future who have no other approved treatment options and who may benefit from this medicine. WLF previously filed comments on April 20, 2005, with the FDA opposing a petition from the Nader group Public Citizen, Inc. in which Public Citizen sought the immediate withdrawal of Iressa.
Case Status:
Awaiting FDA action on comments.
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