Cancer
Amgen in Discussions with FDA to Update U.S. Prescribing Information for ESAs
Published in Blood Weekly, December 27th, 2007
Amgen Inc. (NASDAQ:AMGN) announced the company is in discussions with the U.S. Food and Drug Administration (FDA) with the goal of updating safety information in all erythropoiesis-stimulating agents (ESAs) labeling based on safety data from the recently announced PREPARE interim study results in neoadjuvant breast cancer and the recently published follow up data from the Gynecologic Oncology Group (GOG) study in cervical cancer. While Amgen's interactions with the FDA are ongoing and exact language for the updated labeling is not final, the company is committed to providing timely and appropriate communications to patients and physicians.
Amgen and the FDA are...
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Source: Blood Weekly (2007-12-27)
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