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GENETICS INSTITUTE's BENEFIX LABEL SHOULD WARN OF PK DIFFERENCES FROM PLASMA- DERIVED FACTOR IX, ADVISORY CMTE. SAYS; SAFETY STUDIES TO CONTINUE IN PHASE IV

Executive Summary

"An adjusted dosing algorithm and a prominent warning should be included in the package insert" for Genetics Institute's recombinant Factor IX BeneFix "to accommodate the observed differences in the recovery of plasma-derived coagulation Factor IX, human, and coagulation Factor IX, recombinant," FDA's Blood Products Advisory Committee agreed unanimously Dec. 12.

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