Novartis Prexige NDA Re-Submission Expected In 2006; TARGET Data Are Clean, Firm Says
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.