EXEGEN ATM MINISWINE- patm-neo not applicable 
Exemplar Genetics LLC (dba Precigen Exemplar)

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pATM-Neo in miniswine.

ExeGen ATM miniswine

ExeGen ATM miniswine are geneticaly engineered yucatan miniature swine containing the rDNA construct pATM-Neo which exibit similar phenotypes to human patients with Ataxia Telangiectasia (AT). These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorizaiton 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 both homozygous and heterozygous offspring resulting from a heterozygous founder in which the ATM (ataxia telangiectasia mutated) gene has been disrupted by the homologous recombinaiton of a single copy of a pATM-Neo construct in exon 57, for use in biomedical reseaarch.
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.

See image of warning label "FDA statement 2020.jpg"

warning label

EXEGEN ATM MINISWINE 
patm-neo not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-1801
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 57 (UNII: 2U7SBS8LTK) (HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 57 - UNII:2U7SBS8LTK) HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 571 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-1801-11 [arb'U] in 1 NOT APPLICABLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/09/2018
Labeler - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)

Revised: 4/2019
Document Id: f7814a50-a31c-4dd4-a9b8-ec5931f98d2a
Set id: c3f0d6c9-f2de-4877-99bb-1f01bb44f64f
Version: 4
Effective Time: 20190405
 
Exemplar Genetics LLC (dba Precigen Exemplar)