ExeGen ATM miniswine
- Manufacturer
- Exemplar Genetics LLC (dba Precigen Exemplar)
- Effective date
- 2025-06-05
- Label type
- INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 02:51:44
Label at a glance#
ProductExeGen ATM miniswine
Active ingredientHOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO ...
Label structure1 sections
Contacts and useful links#
Label contents#
Full prescribing information#
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 2020.jpg"
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 86093-1801-1 | ExeGen ATM miniswine | 1 [arb'U] in 1 NOT APPLICABLE | NOT APPLICABLE | 1 | 6 |
Products#
Every source-derived product name is available through these pages.
- ExeGen ATM miniswine
- pATM-Neo
- HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 57
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 86093-1801 | 86093-1801-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HOMOZYGOUS YUCATAN MINIATURE PIG ATAXIA TELANGIECTASIA MUTATED (ATM) GENE DISRUPTED BY A ATM-NEO RDNA CONSTRUCT IN EXON 57 | 2U7SBS8LTK | ACTIM |
Source Document#
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.