Novartis Prexige NDA Re-Submission Expected In 2006; TARGET Data “Clean”
Executive Summary
Novartis expects to re-submit an NDA for the COX-2 inhibitor Prexige by early 2006 following the completion of several studies requested by FDA in a "not approvable" letter
You may also be interested in...
Merck May Need New Arcoxia Trial Design Prior To FDA Approval
Merck may need to conduct additional Arcoxia clinical trials to gain FDA approval after the agency and its COX-2 inhibitor advisory committee cited flaws in the existing program
Merck May Need New Arcoxia Trial Design Prior To FDA Approval
Merck may need to conduct additional Arcoxia clinical trials to gain FDA approval after the agency and its COX-2 inhibitor advisory committee cited flaws in the existing program
Vioxx Cardiovascular Risk Is Unique To Molecule, Pfizer And Novartis Tell FDA
The cardiovascular safety signal observed in Merck's Vioxx may be caused by the formation of potentially toxic rofecoxib metabolites, Pfizer states in its briefing documents for FDA's upcoming review of COX-2 inhibitors