CML Healthcare fenofibrate “approvable”
Executive Summary
CML Healthcare's NDA for a "novel formulation" of fenofibrate (Abbott's triglyceride-lowering agent TriCor) deemed "approvable" by FDA Jan. 13, company says. The agency requested additional details relating to chemistry, manufacturing and labeling for the NDA which was filed in December 2002. In March 2003, Fournier, the French company that licenses TriCor to Abbott, filed suit against CML Healthcare in Puerto Rico federal court. A U.S. federal appeals court recently upheld Chicago federal judge's noninfringement ruling on Teva's generic version of the drug (1"The Pink Sheet" March 31, 2003, In Brief)...