FDA.reportPublic FDA data

ExeGen SCN5A Miniswine

Manufacturer
Exemplar Genetics Llc
Effective date
2025-06-30
Label type
INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:51:50

Label at a glance#

ProductExeGen SCN5A Miniswine
Active ingredientSCN5A-NEO Construct at Exon 11 in Yucatan Minipig (SCNA +/-)
Label structure1 sections

Label contents#

Full prescribing information#

ExeGen SCN5A miniswine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

warning labelwarning label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86093-1902-1ExeGen SCN5A Miniswine1 [arb'U] in 1 PACKAGENOT APPLICABLE14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86093-190286093-1902-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SCN5A-NEO Construct at Exon 11 in Yucatan Minipig (SCNA +/-)08X2W5664OACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.