EXEGEN PKD MINISWINE- ppkd-blast excised not applicable

ExeGen PKD miniswine by

Drug Labeling and Warnings

ExeGen PKD miniswine by is a Other medication manufactured, distributed, or labeled by Exemplar Genetics, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

EXEGEN PKD MINISWINE 
ppkd-blast excised not applicable

Product 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