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coagulation factor IX

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coagulation factor IX (human),
a purified, sterile, dried concentrate of factor IX derived from pooled human plasma, used in the prophylaxis and treatment of bleeding in patients with hemophilia B, administered intravenously.

coagulation factor IX (recombinant),
a sterile, dried concentrate of factor IX prepared by recombinant means, used in the prophylaxis and treatment of bleeding in patients with hemophilia B, administered intravenously.

coagulation factor IX
Factor IX, see there


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said its existing collaboration with LFB Biotechnologies will include work on recombinant human coagulation factor IX.
Lastly, other observations on the 483 included not recording training conditions for qualification of employees performing "the 100% visual inspection," no data to support "product expiry" for labeled storage of Coagulation Factor IX and not storing stability samples in "the worst case manner.
The IND application for the recombinant human coagulation factor IX program is planned for the end of 2010.
 
 
 
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