Generic Propofol Label Differences Argue Against "AB" Rating, Zeneca Says
Executive Summary
"Substantial" differences in the labeling of Gensia Sicor's generic version of Diprivan (propofol) do not support the therapeutic equivalence rating the drug has been given by FDA, Zeneca asserted.
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AstraZeneca Diprivan Anti-Generic Promos Require Corrective Letter - FDA
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Gensia Sicor propofol
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