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Schein Pharmaceutical

Executive Summary

"Coming soon" ad for injectable iron product Ferrlecit cited by agency as promotion of unapproved drug in July 14 letter. The ad touts "an injectable iron therapy in a class of its own." Makoff Labs' NDA for Ferrlecit is "approvable" at FDA; Schein will market the product in the U.S
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PS032648

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