Daily Archives: July 28, 2008

Eisai Gets Thumbs Down Action Letter

Another action from the FDA today that gives a thumbs down to an investigational drug.  Today Eisai announced that it had received a non-approvable letter for the investigational compound fospropofol disodium injection which has been in review at the FDA … Continue reading

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A Not Approvable Letter That Outlines What is Necessary for Approval

This morning, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced receipt of a not approvable letter from the FDA for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.  It is noteworthy on a few fronts. First, it … Continue reading

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