Label: EXEGEN LDLR MINISWINE- pldlr-neo not applicable
- NDC Code(s): 86093-1901-1
- Packager: Exemplar Genetics, LLC
- Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated August 30, 2019
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ExeGen LDLR miniswine
ExeGen LDLR miniswine are genetically engineered yucatan miniature swine containing the rDNA contruct pLDLR-Neo which exhibit similar phenotypes to human patients in which the same LDLR gene is non-funtional. Phenotypes include severely elevated serum cholesterol (total cholesterol and LDL) and atherocsclerosis. These pigs are intended to be used as large animla models of human disease. We will not be requesting a food use authorization and the carcasses and all materials feneated from these animals will be destroyed by incineration.
Product Definition: A specific lin of Yucatan miniatue pigs (Sus scrofa domesticus), indlucing both homozygous and heterozygous offspring resulting from a heterozygous founder, in which the LDLR (low-density lipoprotein receptor) gene has been disrupted by the homologuous recombination of a single copy of a pLDLR-Neo contruct in exon 4, for use in biomedical research.
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 ro 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 LDLR MINISWINE
pldlr-neo not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86093-1901 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength YUCATAN MINIATURE PIG LDLR GENE DISRUPTED BY A LDLR-NEO RDNA CONSTRUCT IN EXON 4 (UNII: D2J8YIK6U6) (pLDLR-Neo - UNII:D2J8YIK6U6) YUCATAN MINIATURE PIG LDLR GENE DISRUPTED BY A LDLR-NEO RDNA CONSTRUCT IN EXON 4 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86093-1901-1 1 [arb'U] in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/05/2019 Labeler - Exemplar Genetics, LLC (958331121) Registrant - Exemplar Genetics, LLC (958331121) Establishment Name Address ID/FEI Business Operations Exemplar Genetics, LLC 958331121 manufacture