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In the News

Amgen Issues Statement in Response to Revised ESA Labeling from the FDA

On July 30, 2008, Amgen issued the following statement in response to the receipt of the complete response on the revised ESA labeling from the FDA.

“This label is consistent with our expectations.  We will soon be communicating the revised product labeling for ESAs to both physicians and patients.”

The potential impact of this revised label was factored into our updated guidance announced July 28, 2008.

Amgen is in the process of finalizing the proposed ESA labels, which will be posted on our Web sites once they are approved by the FDA.  In the meantime, the FDA’s requested red-lined labeling is available on FDA's Web site.


Contact:

Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)


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