Animal NDC 86086-001-01 Ossapig-fh-pcsk9 Miniature Swine
Transposon Of The Pkt2-e/at-pcsk9-d374y Rdna Construct In 1513 Lineage Ossabaw Breed Swine
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 86086-001-01 |
| Proprietary Name | Ossapig-fh-pcsk9 Miniature Swine 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 | Transposon Of The Pkt2-e/at-pcsk9-d374y Rdna Construct In 1513 Lineage Ossabaw Breed Swine 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 | Intentional Animal Genomic Alteration |
| 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. |
Ossapig-fh-pcsk9 Miniature Swine Images
Ossapig-fh-pcsk9 Miniature Swine 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: Single copy insertion of the Sleeping Beauty® transposon of the pKT2-E/AT-PCSK9-D374Y recombinant DNA construct in at least one, but up to three, separate loci (ZCCHC24 locus on chromosome 14 and/or COL21A1 locus on chromosome 7 and/or CDTSP2-ATP23 intergenic locus on chromosome 5) in the 1513 lineage of Ossabaw breed swine (Sus scrofa) known as OssaPig-FH-PCSK9.
Health Claim
Claim: Gain of PCSK9 gene function in the Ossabaw breed of swine produces significantly increased hypercholesterolemia and consistent development of advanced atherosclerosis without the requirement for feeding a high fat and high cholesterol diet. Feeding a high fat and high cholesterol diet accelerates atherosclerosis development.
Contraindications
Limitations: The PCSK9 cDNA used in this model was derived from chimpanzee and codon optimized to swine. Since chimp and human PCSK9 are highly conserved (685/ 692 residues) most protein inhibitors will cross-react. However, due to the codon optimization, RNAi therapy could only be evaluated with custom targets as demonstrated in rodents and non-human primates.
Indications & Usage
Product Use: Model animals and/or materials derived from these animals are intended for purchase only under license agreement with Recombinetics, Inc., and solely for use in connection with the specific licensed biomedical research.
Conditions of Use: This model animal and any products derived from it are for biomedical research purposes only and not for use in humans. This is an investigational animal. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.
References
Manufactured, packaged & distributed by Recombinetics, Inc., under U.S. Veterinary Master File V-006248. Sleeping Beauty transposon is a U.S. registered trademark of Regents of the University of Minnesota.
Warnings And Precautions
Caution. This intentionally genetically altered animal and any products derived from it are for biomedical research purposes only and are not for use in humans or as human or animal food.
OssaPig-FH-PCSK9 animals are not for resale. No reproduction, distribution, transportation, or other third party transfer is allowed by the purchaser unless specifically agreed to in writing by Recombinetics, Inc.
OssaPig-FH-PCSK9 animals, or any materials derived from the OssaPig-PCSK9-FH animals, are not intended to enter the human or animal food supply.
OssaPig-FH-PCSK9 animals shall be euthanized in accordance with all applicable regulatory or industry standards, and all animal remains must be disposed of by incineration. Purchaser must maintain detailed records accounting for the location of all OssaPig-PCSK9-FH animals, and all materials derived from the OssaPig-FH-PCSK9 animals, from the time the animals are delivered to Purchaser through disposition by incineration. Final disposition notification must be made to Recombinetics, Inc.
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
