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Animal NDC 86093-2004-1 Exegen Cln2 Miniswine

Pcln2-blast Excised

Animal Product Information

Field Name Field Value
Animal NDC Code 86093-2004-1
Proprietary Name Exegen Cln2 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 Pcln2-blast Excised 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)
  • Cln2 Rdna Construct Disrupting Exon 6 Of Cln2 Gene In Yucatan Miniature Swine
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 Cln2 Miniswine Images

Exegen Cln2 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 Cln2 Miniswine



ExeGen CLN2 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pCLN2 which exhibit similar phenotypes to human patients with CLN2 disease. These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorization 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 homozygous and heterozygous offspring resulting from a heterozygous founder, in which the CLN2 gene has been disrupted by the homologous recombination of a single copy of a mutated CLN2-PGK construct in exon 6 for use in biomedical research. The desirable animal will be a homozygote CLN2 R208X Blast Excised/R208X 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.


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