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

  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated July 24, 2024

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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 TypeItem 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.829874523manufacture
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