Label: EXEGEN CLN3 MINISWINE- pcln3-neo excised not applicable

  • NDC Code(s): 86093-2001-1
  • 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 January 15, 2020

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  • ExeGen CLN3 miniswine

    ExeGen CLN3 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pCLN3-Neo Excised which exhibit similar phenotypes to human patients with CLN3 disease. 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 homozygous offspring resulting from a heterozygous founder, in which the CLN3 gene has been disrupted by the homologous recombination of a single copy of a mutated CLN3-PGK construct for use in biomedical research. The desirable animal will be a homozygote CLN3 Ex7-8del Neo Excised/Ex7-8del Neo 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 or release contact Exemplar Genetics at 712-722-2767 or 712-441-3408.

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  • INGREDIENTS AND APPEARANCE
    EXEGEN CLN3 MINISWINE 
    pcln3-neo excised not applicable
    Product Information
    Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-2001
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE (UNII: E3SP91Q3EF) (CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE - UNII:E3SP91Q3EF) CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE1 [arb'U]  in 1 [arb'U]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86093-2001-11 [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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