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Ferrlecit Generic To Get 3-Part Evaluation After FDA Worry On Therapeutic Equivalence

This article was originally published in The Pink Sheet Daily

Executive Summary

Actavis’ version of Sanofi’s brand comes under scrutiny after EU guidance suggests generic iron formulations could have higher levels of labile iron and that study of plasma levels alone “may conceivably fail to detect relevant differences in the tissue distribution of iron.”

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