US FDA declares Novartis painkiller Prexige is ''not approvable''
28 Sep 2007
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The US Food and Drug Administration (FDA) has refused to grant a license to pharma major Novartis''s new painkiller, ''Prexige''.
The Basel, Switzerland-based pharmaceutical company received a "not approvable" rejection letter from the FDA for Prexige, which it had proposed as a once-daily treatment for patients suffering from osteoarthritic pain.
The
setback was widely expected after the drug was withdrawn in Australia earlier
this year, after it was blamed for the deaths of two people and for triggering
liver failures that required two others to have liver transplants.
