Label: EXEGEN PKD MINISWINE- ppkd-blast excised not applicable
- NDC Code(s): 86093-2002-1
- Packager: Exemplar Genetics, Llc
- Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated February 12, 2020
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ExeGen PKD miniswine
ExeGen PKD miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pPKD-Blast which exhibit similar phenotypes to human patients with PKD. 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 PKD1 gene has been disrupted by the homologous recombination of a single copy of a mutated PKD1-PGK construct resulting in a point mutation for use in biomedical research. The desirable animal will be a heterozygote PKD1 +/R3277C Blast 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 PKD MINISWINE
ppkd-blast excised not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86093-2002 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HETEROZYGOUS YUCATAN MINIATURE PKD MUTATED GENE DISRUPTED BY A PKD-BLAST RDNA CONSTRUCT RESULTING IN MUTATION R3278C (UNII: E3SP91Q3EF) (pPKD-BLAST Excised - UNII:E3SP91Q3EF) HETEROZYGOUS YUCATAN MINIATURE PKD MUTATED GENE DISRUPTED BY A PKD-BLAST RDNA CONSTRUCT RESULTING IN MUTATION R3278C 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86093-2002-1 1 [arb'U] in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2020 Labeler - Exemplar Genetics, Llc (958331121) Registrant - Exemplar Genetics, Llc (958331121) Establishment Name Address ID/FEI Business Operations Exemplar Genetics, Llc 958331121 manufacture