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Animal NDC 86093-1801-1 Exegen Atm Miniswine

Patm-neo

Animal Product Information

Field Name Field Value
Animal NDC Code 86093-1801-1
Proprietary Name Exegen Atm Miniswine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Patm-neo What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Exemplar Genetics Llc (dba Precigen Exemplar)
Product Type Recombinant Deoxyribonucleic Acid Construct
Active Ingredient(s)
  • Homozygous Yucatan Miniature Pig Ataxia Telangiectasia Mutated (atm) Gene Disrupted By A Atm-neo Rdna Construct In Exon 57
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Exegen Atm Miniswine Images

Exegen Atm Miniswine Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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"


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.