Bio Products Laboratory announced that the Food and Drug Administration (FDA) has accepted for review the amended Biologics License Application (BLA) for Coagadex (coagulation factor X, human) for hereditary X deficiency.

Coagadex is an investigational, high purity human factor X concentrate. Previously the FDA has granted Orphan Drug designation to Coagadex for the treatment of hereditary factor X deficiency. The FDA is currently reviewing data from two Phase 3 trials of Coagadex.

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Currently there are no factor X products specifically approved by the FDA for the treatment of patients with hereditary factor X deficiency.

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