Label: EXEGEN NF1 MINISWINE- pnf1-blast excised not applicable
- NDC Code(s): 86093-1903-2
- Packager: Exemplar Genetics, Llc
- Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Drug Label Information
Updated August 15, 2019
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ExeGen NF1 miniswine
ExeGen NF1 miniswine are geneticaly engineered yucatan miniature swine containing the rDNA construct pNF1-Blast which exibit similar phenotypes to human patients with Neurofibromatosis. 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 heterozygous offspring resulting from a heterozygous founder, in which the NF1 gene has been disrupted by the homologous recombination of a single copy of a mutated NF1-PGK construct resulting in the deletion of exon 42 for use in biomedical research. The final sellable animal will be a heterozygous NF1 +/Ex42del Blast 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 NF1 MINISWINE
pnf1-blast excised not applicableProduct Information Product Type RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL Item Code (Source) NDC:86093-1903 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HETEROZYGOUS YUCATAN MINIATURE NF1 MUTATED GENE DISRUPTED BY A NF1-BLAST RDNA CONSTRUCT RESULTING IN THE DELETION OF EXON 42 (UNII: JJB5COM59I) (pNF1-Blast Excised - UNII:JJB5COM59I) HETEROZYGOUS YUCATAN MINIATURE NF1 MUTATED GENE DISRUPTED BY A NF1-BLAST RDNA CONSTRUCT RESULTING IN THE DELETION OF EXON 42 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86093-1903-2 1 [arb'U] in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/14/2020 Labeler - Exemplar Genetics, Llc (958331121) Registrant - Exemplar Genetics, Llc (958331121) Establishment Name Address ID/FEI Business Operations Exemplar Genetics, Llc 958331121 manufacture