Dr.Vikram
unread,Aug 1, 2008, 3:22:33 AM8/1/08Sign in to reply to author
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to pharmacovigilance
FDA asks Amgen to re-word label.
The FDA has asked Amgen to revise labels for Aranesp, Epogen and
Procrit to include warnings that would further limit the anemia drugs'
use in cancer patients, including those undergoing chemotherapy. Amgen
will notify patients and doctors about the changes, which the company
said were consistent with its expectations. Johnson & Johnson, which
markets Procrit, said it will work with the FDA to implement the
updated label.
Dr.Vikram.k
Source: The new york times.Jul31,08