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

PRLR-SLICK Cattle by

Drug Labeling and Warnings

PRLR-SLICK Cattle by is a Other medication manufactured, distributed, or labeled by Recombinetics, Inc., Acceligen, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL	Item Code (Source)	NDC: 86086-006
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 TAURUS	1 [arb'U]  in 1 [arb'U]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86086-006-01	1 [arb'U] in 1 NOT APPLICABLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2022

Labeler - Recombinetics, Inc. (829874523)

Registrant - Acceligen, Inc. (108237218)

Establishment
Name	Address	ID/FEI	Business Operations
Recombinetics, Inc.		829874523	api manufacture