labels: oct_2001, novartis
US FDA declares Novartis painkiller Prexige is ''not approvable'' news
28 September 2007

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The setback was widely expected after the drug was withdrawn in Australia earlier this year, after it was blamed for the deaths of two people and for triggering liver failures that required two others to have liver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.


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US FDA declares Novartis painkiller Prexige is ''not approvable''