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Animal NDC 86134-001-01 Galsafe

Ppl657 Rdna Construct In Domestic Pigs

Animal Product Information

Field Name Field Value
Animal NDC Code 86134-001-01
Proprietary Name Galsafe 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 Ppl657 Rdna Construct In Domestic Pigs 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 Revivicor Inc.
Product Type Intentional Animal Genomic Alteration
Active Ingredient(s)
  • Ppl657 Rdna Construct In The Ggta1 Gene In Domestic Pigs
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION 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.
FDA Application Number NADA141542 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

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Galsafe 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



1. Product Identification



pPL657 rDNA construct in the glycoprotein galactosyltransferase alpha-1,3 gene (GGTA1) in the hemizygous and homozygous GalSafe®

GalSafe® is the registered tradename for Revivicor’s lineage of pigs and is not itself subject to FDA approval. Rather, the regulated article subject to FDA approval is the intentional genomic alteration (pPL657 rDNA construct), which is contained in the GalSafe® lineage of pigs.

lineage of domestic pigs (Sus scrofa domesticus) resulting in undetectable endogenous galactose-alpha-l,3-galactose sugar residues on biological derivatives of the homozygous GalSafe® lineage that are intended to be used as sources of food or human therapeutics including excipients, devices, drugs, or biological products.


2. Warnings And Precautions



2. Food Safety Warnings:


a. To mitigate the potential development of bacterial resistance to aminoglycoside antimicrobial drugs, GalSafe® pigs should not be treated with an aminoglycoside.


b. Other Warnings:
   The GalSafe® lineage must only be housed in physically contained facilities specified in the approved application.

To report suspected adverse events or request other technical assistance, please contact Customer Support at 540-961-5559 or www.revivicor.com. For additional information about adverse drug experience reporting, contact FDA at 1.888.FDA.VETS or www.fda.gov/reportanimalae.


3. Target Animal Safety



Data from the GalSafe® lineage demonstrated a lack of adverse effects for the pPL657 rDNA construct in the GalSafe® pigs vs. comparator pigs without an intentional genomic alteration (IGA).

With respect to reproductive outcomes, litter characteristics of GalSafe® pigs were evaluated on a quarterly basis using data collected during 2012-2018. Quarterly means, with standard deviations, and ranges are provided in Table 1 below:

Table 1. Summary statistics for litter characteristics of pigs in the GalSafe® herd based on the summary of quarterly values during 2012-2018 (101 litters and 656 piglets born).
Observation Mean Standard Deviation Minimum Maximum
  Total Piglets Born/Litter (n)8.12.83.016.0
 Live Piglets at Birth/Litter (n)7.42.92.0 16.0
 Mortality at Birth/Litter (n)0.80.7 0.0 3.0
 Pre-Weaning Mortality/Litter (n)1.91.1 0.0 4.0
 Weaned Piglets/Litter (n)5.42.8 2.0 13.0
 Birth Weight/Piglet (lb.)2.50.4 1.9 3.6
 Mortality at Birth (%)10.010.0 0.0 35.0
 Pre-Weaning Mortality (%)25.014.0 0.0 56.0

Overall morbidity and mortality for post-weaned (growing and breeding populations) GalSafe® pigs were evaluated on a quarterly basis using data collected during 2012-2018. Quarterly means, with standard deviations, and ranges are provided in Table 2 below:

Table 2. Summary statistics for overall morbidity and mortality of post-weaned (growing and breeding populations) GalSafe® pigs based on the summary of quarterly values (2012-2018). 
 aoverall morbidity based on recorded therapy (Rx) events for health observations in systems/categories such as the following: reproductive, lameness (hoof, limbs), respiratory, gastrointestinal, skin/integument, or central nervous system
ObservationMeanStandard DeviationMinimumMaximum
Mortality Number of pigs/Quarter (n) 0.71.10.04.0
 % 1.42.00.06.7
Morbiditya Number of pigs/Quarter (n) 6.6 4.11.019.0
 % 15.3 9.82.642.9


 In a study to compare physiological endpoints in GalSafe® pigs vs. comparator pigs (comparators) without an intentional genomic alteration (IGA), blood samples were collected for evaluations. No differences between GalSafe® and comparators were evident based on the following evaluations: serology, CBC (complete blood count) and comprehensive blood chemistry. Values were within expected physiological ranges.


4. Effectiveness



Multiple generations of the GalSafe® line have demonstrated genetic consistency as established through genetic tests for the presence of the pPL657 rDNA construct, pPL657 rDNA sequence fidelity and pPL657 rDNA construct integration site consistency. For multiple consecutive generations, phenotypic consistency has been established based on the undetectable levels of galactose-alpha-1,3-galactose sugar residues on biological derivatives of homozygous GalSafe® pigs.

Produced by:
Revivicor, Inc., wholly owned subsidiary of
United Therapeutics
1700 Kraft Dr, Suite 2400
Blacksburg, VA 24060 USA

Customer Support: 540-961-5559 www.revivicor.com

Approved by FDA under NADA #141-542


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.