OssaPig-LD-NASH Miniature Swine

Manufacturer
Recobimbinetics, Inc. | Recombinetics, Inc.
Effective date
2026-05-20
Label type
INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:52:58

Label at a glance#

ProductOssaPig-LD-NASH Miniature Swine
Active ingredientSUS SCROFA G.(NC_010447.5) 5087853-5087855GAC>CTG+5087858G>C+5087861T>C+5087864C>G+5087871-508787...
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

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 SECTION

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 SECTION

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 SECTION

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.

INDICATIONS & USAGE SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container/Carton LabelContainer/Carton Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86086-004-01OssaPig-LD-NASH Miniature Swine1 [arb'U] in 1 NOT APPLICABLENOT APPLICABLE15

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86086-00486086-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.