Label: EXEGEN ATM MINISWINE- patm-neo not applicable
- NDC Code(s): 86093-1801-1
- 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 5, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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"
-
INGREDIENTS AND APPEARANCE
EXEGEN ATM MINISWINE
patm-neo not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86093-1801 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 57 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86093-1801-1 1 [arb'U] in 1 NOT APPLICABLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/09/2018 Labeler - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)