Animal NDC 86086-004-01 Ossapig-ld-nash Miniature Swine
Pnpla3 Hindiii Restriction Fragment Length Polymorphism (rflp) Positive For One Or Two Copies Of Pnpla3-i148m
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 86086-004-01 |
| Proprietary Name | Ossapig-ld-nash 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 | Pnpla3 Hindiii Restriction Fragment Length Polymorphism (rflp) Positive For One Or Two Copies Of Pnpla3-i148m 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 | Recobimbinetics, 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. |
Ossapig-ld-nash Miniature Swine Images
Ossapig-ld-nash 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: Transcription activator-like effector nuclease (TALEN) edit and homology dependent repair in Ossabaw breed porcine fetal fibroblasts to introduce a CTC>GAA base substitution at base pairs 5,087,871-5,087,873 that generates a HindIII restriction enzyme site used to genotype progeny from gene edited founders, a C>G base substitution at base pair 5,087,864 that creates a coding sequence change from isoleucine to methionine at amino acid 148 of the swine PNPLA3 protein, and synonymous base substitutions; T>C at base pair 5,087,861 and G>C at base pair 5,087,858 and GAC>CTG at base pairs 5,087,853-5,087,855.
Health Claim
Claim: Change of PNPLA3 gene function as a result of this gene edit in the Ossabaw breed of swine reproduces the human genetic polymorphism associated with diagnosis of non-alcoholic steatohepatitis (NASH).
Contraindications
Limitations: This is a model of progressive disease. Disease symptoms associated with non-alcoholic steatohepatitis disease in humans take time to develop, and like the human disease, are variable in presentation from animal to animal.
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.
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-LD-NASH 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-LD-NASH animals, or any materials derived from the OssaPig-LD-NASH animals, are not intended to enter the human or animal food supply.
OssaPig-LD-NASH 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-LD-NASH animals, and all materials derived from the OssaPig-LD-NASH 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.