Animal NDC 86086-002-01 Ossapig-nf-nf1(fs41) Miniature Swine
Nf1 Hindiii Restriction Fragment Length Polymorphism (rflp) Positive For Nf1-r1947 Stop Codon In Ossabaw Breed Swine

Animal Product Information

Field Name Field Value
Animal NDC Code 86086-002-01
Proprietary Name Ossapig-nf-nf1(fs41) 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 Nf1 Hindiii Restriction Fragment Length Polymorphism (rflp) Positive For Nf1-r1947 Stop Codon In 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 Recombinant Deoxyribonucleic Acid Construct
Usage Information
    Limitations: This is a model of progressive disease. Some of the disease symptoms associated with Neurofibromatosis Type I disease in humans take time to develop, and like the human disease, are variable in presentation from animal to animal.
Active Ingredient(s)
  • Sus Scrofa G.(nc_010454.4)43530892c>t + 43530890_43530889insagctt In Ossabaw 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.

Ossapig-nf-nf1(fs41) Miniature Swine Images

Ossapig-nf-nf1(fs41) 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 C>T base substitution at base pair 43,530,892 and insertion of five nucleotides between base pairs 43,308,890 and 43,530,889 of Sus scrofa chromosome 12 (NC_010454.4). The base substitution generates a premature stop codon in the coding sequence for the neurofibromin protein and the five nucleotide insertion generates a HindIII restriction enzyme site used to genotype progeny from gene edited founders.


Health Claim



Claim: Loss of NF1 gene function as a result of this gene edit in the Ossabaw breed of swine produces symptoms consistent with the National Institutes of Health (NIH) criteria for diagnosis of Neurofibromatosis Type I disease in humans.


Contraindications



Limitations: This is a model of progressive disease. Some of the disease symptoms associated with Neurofibromatosis Type I 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-NF-NF1(FS41) 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-NF-NF1(FS41) animals, or any materials derived from the OssaPig-NF-NF1(FS41) animals, are not intended to enter the human or animal food supply.
OssaPig-NF-NF1(FS41) 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-NF-NF1(FS41) animals, and all materials derived from the OssaPig-NF-NF1(FS41) 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.