Novartis Prexige NDA Re-Submission Expected In 2006; TARGET Data Are Clean, Firm Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Novartis had earlier predicted a lumiracoxib launch in 2005, should FDA accept existing data to satisfy a request for a hip osteoarthritis study. The long-term TARGET study data have been unblinded, and Novartis sees no “surprises” with regard to Prexige’s liver or cardiovascular safety.
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