Posts for Ticker ‘cancer pain drug’

Cephalon’s FDA Warning More of a Formality (CEPH)

Cephalon Inc. (NASDAQ:CEPH) is a biotech that has been under a bit of a low ceiling after its recent blunder regarding FENTORA.  As a reminder FENTORA is that cancer pain drug that the company issued "Dear Doctor" alerts about the potential side effects possibly leading to deaths.  The company said it believes that the deaths were the result of improper matches, improper dosing, and substitutions for other drugs. 

Cephalon gave its own warnings on this, and today the Food & Drug Administration has sent out communication of its own with warnings to pay close attention to the same issues.  Of course it included that the FDA was closely reviewing and monitoring the situation.  The long and short of it is that this is a mere formality out of the FDA and would have been expected.  There is not really any new data in the FDA letter, other than the fact the letter is out now.

Jon C. Ogg
September 26, 2007

Below is a copy of the electronic communication from the FDA:

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Posted on: September 26, 2007 – 1:12 pm in Biotech, FDA, , , ,