Novartis Withdraws Prexige In Australia Ahead Of FDA Decision Due To Deaths
This article was originally published in PharmAsia News
A decision to withdraw Novartis' Prexige (lumiracoxib) in Australia after two patients died from serious liver injury following treatment with the drug is likely to impact the outcome of FDA's decision on a pending NDA for the COX-2 inhibitor
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Novartis expects action later this year on lumiracoxib after resubmitting the application, the company tells “The Pink Sheet” DAILY.
Agency indicates more data is needed on benefit-to-risk profile of the COX-2 inhibitor, but Merck is mum on whether it will continue to pursue approval.
Company takes a more bullish stance on its COX-2 inhibitor than Merck, which has assumed FDA approval of its Vioxx follow-on product Arcoxia in 2007.