EXEGEN SCN5A MINISWINE- pscn5a-neo not applicable

ExeGen SCN5A Miniswine by

Drug Labeling and Warnings

ExeGen SCN5A Miniswine by is a Other medication manufactured, distributed, or labeled by Exemplar Genetics Llc, Exemplar Genetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ExeGen SCN5A miniswine

ExeGen SCN5A miniswine are geneticaly engineered yucatan miniature swine containing the rDNA construct pSCN5A-Neo which exibit similar phenotypes to human patients with sudden arrhythmia death syndromes (SADS). 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 SCN5A gene has been disrupted by the homologous recombinaiton of a single copy of a pSCN5A-Neo construct in exon 11, 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 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 SCN5A MINISWINE 
pscn5a-neo not applicable

Product Information
Product Type	RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL	Item Code (Source)	NDC: 86093-1902
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HETERZYGOUS YUCATAN MINIATURE PIG SCN5A MUTATED GENE DISRUPTED BY A SCN5A-NEO RDNA CONSTRUCT IN EXON 11 (UNII: 08X2W5664O) (pSCN5A-Neo - UNII:08X2W5664O)	HETERZYGOUS YUCATAN MINIATURE PIG SCN5A MUTATED GENE DISRUPTED BY A SCN5A-NEO RDNA CONSTRUCT IN EXON 11	1 [arb'U]  in 1 [arb'U]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86093-1902-1	1 [arb'U] in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2019

Labeler - Exemplar Genetics Llc (958331121)

Registrant - Exemplar Genetics LLC (958331121)

Establishment
Name	Address	ID/FEI	Business Operations
Exemplar Genetics LLC		958331121	manufacture