EXEGEN ATM MINISWINE- patm-neo not applicable

ExeGen ATM miniswine by

Drug Labeling and Warnings

ExeGen ATM miniswine by is a Other medication manufactured, distributed, or labeled by Exemplar Genetics LLC (dba Precigen Exemplar). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ExeGen ATM miniswine

ExeGen ATM miniswine are geneticaly engineered yucatan miniature swine containing the rDNA construct pATM-Neo which exibit similar phenotypes to human patients with Ataxia Telangiectasia (AT).  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 both homozygous and heterozygous offspring resulting from a heterozygous founder in which the ATM (ataxia telangiectasia mutated) gene has been disrupted by the homologous recombinaiton of a single copy of a pATM-Neo construct in exon 57, for use in biomedical reseaarch. 

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. 

See image of warning label "FDA statement 4-8-16.jpg"

INGREDIENTS AND APPEARANCE

EXEGEN ATM MINISWINE 
patm-neo not applicable

Product Information
Product Type	RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL	Item Code (Source)	NDC: 86093-1801
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 57 (UNII: 2U7SBS8LTK) (HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 57 - UNII:2U7SBS8LTK)	HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 57	1 [arb'U]  in 1 [arb'U]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86093-1801-1	1 [arb'U] in 1 NOT APPLICABLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/09/2018

Labeler - Exemplar Genetics, Llc (958331121)