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Animal NDC 86093-1901-1 Exegen Ldlr Miniswine

Pldlr-neo

Animal Product Information

Field Name Field Value
Animal NDC Code 86093-1901-1
Proprietary Name Exegen Ldlr 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 Pldlr-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
Product Type Recombinant Deoxyribonucleic Acid Construct
Active Ingredient(s)
  • Pldlr-neo
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 Ldlr Miniswine Images

Exegen Ldlr 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 Ldlr Miniswine



ExeGen LDLR miniswine are genetically engineered yucatan miniature swine containing the rDNA contruct pLDLR-Neo which exhibit similar phenotypes to human patients in which the same LDLR gene is non-funtional. Phenotypes include severely elevated serum cholesterol (total cholesterol and LDL) and atherocsclerosis. These pigs are intended to be used as large animla models of human disease. We will not be requesting a food use authorization and the carcasses and all materials feneated from these animals will be destroyed by incineration.


Product Definition: A specific lin of Yucatan miniatue pigs (Sus scrofa domesticus), indlucing both homozygous and heterozygous offspring resulting from a heterozygous founder, in which the LDLR (low-density lipoprotein receptor) gene has been disrupted by the homologuous recombination of a single copy of a pLDLR-Neo contruct in exon 4, 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 ro 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.


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