Label: PRLR-SLICK CATTLE- prlr gene edit in at least one copy producing protein truncation at or between amino acids 433 to 497 not applicable

  • Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated January 19, 2022

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  • STATEMENT OF IDENTITY

    Identity: CRISPR-Cas9 editing with or without homology dependent repair in heat-susceptible beef breeds to introduce mutations into at least one copy of the PRLR gene of Bos taurus chromosome 20 (NC_037347.1). The intended mutations generate a premature stop codon in the coding sequence resulting in a truncated PRLR protein and a SLICK coat phenotype.

  • HEALTH CLAIM

    Claim: Mutations causing PRLR protein truncation at or between amino acids 433 to 497 produce a SLICK coat phenotype that is reported to be linked to increased thermotolerance in Bos taurus species raised in sub-tropical environments.

  • INDICATIONS & USAGE

    Product Use: Founder animals are intended for production and sale of seed stock and/or embryos to enable the establishment of PRLR-SLICK thermotolerant beef herds that will be used as a food source. Due to the specific process used to produce these animals, they may have 2 or more genetically different sets of cells, and as a result the PRLR-SLICK thermotolerant phenotype may not be inherited by all first generation progeny.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PRLR-SLICK CATTLE 
    prlr gene edit in at least one copy producing protein truncation at or between amino acids 433 to 497 not applicable
    Product Information
    Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86086-006
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SLICK ALTERATION DISRUPTING BOS TAURUS G.(NC_037347.1) FS(39099129-39099368) IN EXON 9 OF PRLR GENE IN BOS TAURUS (UNII: B8K52Z76YK) (SLICK ALTERATION DISRUPTING BOS TAURUS G.(NC_037347.1) FS(39099129-39099368) IN EXON 9 OF PRLR GENE IN BOS TAURUS - UNII:B8K52Z76YK) SLICK ALTERATION DISRUPTING BOS TAURUS G.(NC_037347.1) FS(39099129-39099368) IN EXON 9 OF PRLR GENE IN BOS TAURUS1 [arb'U]  in 1 [arb'U]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86086-006-011 [arb'U] in 1 NOT APPLICABLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2022
    Labeler - Recombinetics, Inc. (829874523)
    Registrant - Acceligen, Inc. (108237218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Recombinetics, Inc.829874523api manufacture
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