Label: EXEGEN MYH7 MINISWINE- pmyh7-blast excised not applicable

  • NDC Code(s): 86093-2003-1
  • Packager: Exemplar Genetics LLC (dba Precigen Exemplar)
  • Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated April 10, 2020

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  • ExeGen MYH7 miniswine

    ExeGen MYH7 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pMYH7-Blast which exhibit similar phenotypes to human patients with HCM. These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorization and the carcasses and all materials generated from these animals will be destroyed by incineration.

    Product Definition: A specific line of Yucatan miniature pigs (Sus scrofa domesticus), including heterozygous offspring resulting from a heterozygous founder, in which the MYH7 gene has been disrupted by the homologous recombination of a single copy of a mutated MYH7-PGK construct resulting in the mutation R403Q for use in biomedical research. The final sellable animal well be a heterozygote MYH7 +/R403Q Blast Excised miniswine.

    Warning: This product is from a genetically engineered animal and may contain an investigational new animal drug. It is for research purposes only and not for use in humans or as food/feed unless authorization has been granted by the US Food and Drug Administration. In case of emergency release contact Exemplar Genetics at 712-722-2767 or 712-441-3408.

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  • INGREDIENTS AND APPEARANCE
    EXEGEN MYH7 MINISWINE 
    pmyh7-blast excised not applicable
    Product Information
    Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-2003
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE (UNII: 0A87T8ALI3) (MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE - UNII:0A87T8ALI3) MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE1 [arb'U]  in 1 [arb'U]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86093-2003-11 [arb'U] in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/15/2020
    Labeler - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)
    Registrant - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Exemplar Genetics LLC (dba Precigen Exemplar)958331121manufacture
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