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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memo - Nonclinical Labeling - Corifact

To:                     File (STN 125385 BLA CorifactTM Label)      

From:                 La’Nissa A. Brown-Baker, Ph.D., Pharmacologist, Division of Hematology (DH)/OBRR         

Through:            Iftekhar Mahmood, Ph.D., Team Lead, DH/OBRR     

For:                    Original BLA STN 125385/0- Human FXIII, CorifactTM Nonclinical Labeling Information Request                 

Letter-Ready Comments:

  1. Please include a section 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility under CorifactTM Nonclinical Toxicology label. The following information should be included in section 13.1:

    Long-term animal studies have not been performed to evaluate the carcinogenic potential of [Trade name] or studies to determine genotoxicity or the effect of [Trade name] on fertility

  2. Please clarify the duration (length of time) for repeat dose toxicity study in rats in line 296 of Nonclinical Toxicology section for CorifactTM label.