GALSAFE- ppl657 rdna construct in domestic pigs not applicable

GalSafe by

Drug Labeling and Warnings

GalSafe by is a Other medication manufactured, distributed, or labeled by Revivicor Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

  • PRINCIPAL DISPLAY PANEL

    pPL657 rDNA construct in the GGTA1 gene in domestic pigs

    pPL657 rDNA construct in the GGTA1 gene in domestic pigs
    pPL657 rDNA construct in the GGTA1 gene in domestic pigs
  • INGREDIENTS AND APPEARANCE
    GALSAFE 
    ppl657 rdna construct in domestic pigs not applicable
    Product Information
    Product TypeItem Code (Source)NDC: 86134-001
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pPL657 rDNA construct in the GGTA1 gene in domestic pigs (UNII: JUB9QR42SC) (pPL657 rDNA construct in the GGTA1 gene in domestic pigs - UNII:JUB9QR42SC) pPL657 rDNA construct in the GGTA1 gene in domestic pigs1 [arb'U]  in 1 [arb'U]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 86134-001-011 [arb'U] in 1 NOT APPLICABLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14154201/04/2021
    Labeler - Revivicor Inc. (805253937)

  • Trademark Results [GalSafe]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GALSAFE
    GALSAFE
    88564854 not registered Live/Pending
    Revivicor, Inc.
    2019-08-02
    GALSAFE
    GALSAFE
    88564774 not registered Live/Pending
    Revivicor, Inc.
    2019-08-02
    GALSAFE
    GALSAFE
    77461499 3818952 Live/Registered
    Revivicor, Inc.
    2008-04-30

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