PRLR-SLICK Cattle

Manufacturer
Recombinetics, Inc. | Acceligen, Inc.
Effective date
2024-07-24
Label type
INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:51:06

Label at a glance#

ProductPRLR-SLICK Cattle
Active ingredientSLICK ALTERATION DISRUPTING BOS TAURUS G.(NC_037347.1) FS(39099129-39099368) IN EXON 9 OF PRLR GE...
Label structure4 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

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 SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86086-006-01PRLR-SLICK Cattle1 [arb'U] in 1 NOT APPLICABLENOT APPLICABLE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86086-006PRLR-SLICK CATTLE (PRLR GENE EDIT IN AT LEAST ONE COPY PRODUCING PROTEIN TRUNCATION AT OR BETWEEN AMINO ACIDS 433 TO 497) NOT APPLICABLE [RECOMBINETICS, INC.]41 package rows20240726_423a7b9c-9f78-4461-a2de-7e9ee34c12ee.zip

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86086-00686086-006-01

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.