CELTIC POLLED CATTLE- celtic polled alteration on bovine autosomal chromosome 1 not applicable

Celtic Polled Cattle by

Drug Labeling and Warnings

Celtic Polled Cattle by is a Other medication manufactured, distributed, or labeled by Acceligen, Recombinetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Identity: CRISPR-Cas12a editing with homology dependent repair in cattle to introduce two copies of the Celtic allele of Bos taurus chromosome 1 (NC_037328.1). The intended mutations resulted in presence of a known polled genotype variation already present within the species.

HEALTH CLAIM

Claim: The homozygous Celtic allele will allow the introduction of a polled phenotype into horned cattle.

INDICATIONS & USAGE

Product Use: Founder animals are intended for production and sale of semen to enable the establishment of polled herds, the progeny of which will be used as a food source.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CELTIC POLLED CATTLE 
celtic polled alteration on bovine autosomal chromosome 1 not applicable

Product Information
Product Type		Item Code (Source)	NDC: 86251-001
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BOS TAURUS G.(NC_037328.1) DUP(2429109-2429320) + DEL(2429327-2429336) (UNII: MXA2P479Z3) (BOS TAURUS G.(NC_037328.1) DUP(2429109-2429320) + DEL(2429327-2429336) - UNII:MXA2P479Z3)	BOS TAURUS G.(NC_037328.1) DUP(2429109-2429320) + DEL(2429327-2429336)	1 [Amb'a'1'U]  in 1 [Amb'a'1'U]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86251-001-01	1 [Amb'a'1'U] in 1 NOT APPLICABLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/09/2026

Labeler - Acceligen (108237218)

Registrant - Acceligen (108237218)

Establishment
Name	Address	ID/FEI	Business Operations
Recombinetics		829874523	manufacture