Gensia Sicor propofol

Executive Summary

Baltimore federal court finds that FDA appropriately approved Gensia Sicor's generic propofol despite the use of a different preservative than that used in Zeneca's Diprivan. The Aug. 11 ruling grants the company and FDA's motion for summary judgment in a suit brought by Zeneca in February that sought reversal of FDA's approval of the propofol ANDA. Zeneca had argued that FDA's therapeutic equivalence rating for the generic propofol was inappropriate given "substantial" labeling differences between the products (1"The Pink Sheet" Feb. 15, p. 22). Zeneca said it is considering an appeal