Animal NDC 86086-006-01 Prlr-slick Cattle
Prlr Gene Edit In At Least One Copy Producing Protein Truncation At Or Between Amino Acids 433 To 497
Animal Product Information
Field Name | Field Value |
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Animal NDC Code | 86086-006-01 |
Proprietary Name | Prlr-slick Cattle 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 | Prlr Gene Edit In At Least One Copy Producing Protein Truncation At Or Between Amino Acids 433 To 497 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 | Recombinetics, Inc. |
Product Type | Recombinant Deoxyribonucleic Acid Construct |
Usage Information |
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Active Ingredient(s) |
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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. |
Prlr-slick Cattle 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
Statement Of Identity
Identity: CRISPR-Cas9 editing with or without homology dependent repair in heat-susceptible beef breeds to introduce mutations into at least one copy of the PRLR gene of Bos taurus chromosome 20 (NC_037347.1). The intended mutations generate a premature stop codon in the coding sequence resulting in a truncated PRLR protein and a SLICK coat phenotype.
Health Claim
Claim: Mutations causing PRLR protein truncation at or between amino acids 433 to 497 produce a SLICK coat phenotype that is reported to be linked to increased thermotolerance in Bos taurus species raised in sub-tropical environments.
Indications & Usage
Product Use: Founder animals are intended for production and sale of seed stock and/or embryos to enable the establishment of PRLR-SLICK thermotolerant beef herds that will be used as a food source. Due to the specific process used to produce these animals, they may have 2 or more genetically different sets of cells, and as a result the PRLR-SLICK thermotolerant phenotype may not be inherited by all first generation progeny.
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