FDA.reportPublic FDA data

ExeGen NF1 miniswine

Manufacturer
Exemplar Genetics, Llc
Effective date
2025-06-16
Label type
INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:51:46

Label at a glance#

ProductExeGen NF1 miniswine
Active ingredientNF1 RDNA CONSTRUCT AT EXON 42 IN YUCATAN MINIPIG (+/-)
Label structure1 sections

Label contents#

Full prescribing information#

ExeGen NF1 miniswine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86093-1903-2ExeGen NF1 miniswine1 [arb'U] in 1 PACKAGENOT APPLICABLE13

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
86093-190386093-1903-2

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
NF1 RDNA CONSTRUCT AT EXON 42 IN YUCATAN MINIPIG (+/-)JJB5COM59IACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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