EXEGEN MYH7 MINISWINE- pmyh7-blast excised not applicable 
Exemplar Genetics LLC (dba Precigen Exemplar)

----------

pMYH7 in miniswine

ExeGen MYH7 miniswine

ExeGen MYH7 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pMYH7-Blast which exhibit similar phenotypes to human patients with HCM. These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorization and the carcasses and all materials generated from these animals will be destroyed by incineration.

Product Definition: A specific line of Yucatan miniature pigs (Sus scrofa domesticus), including heterozygous offspring resulting from a heterozygous founder, in which the MYH7 gene has been disrupted by the homologous recombination of a single copy of a mutated MYH7-PGK construct resulting in the mutation R403Q for use in biomedical research. The final sellable animal well be a heterozygote MYH7 +/R403Q Blast Excised miniswine.

Warning: This product is from a genetically engineered animal and may contain an investigational new animal drug. It is for research purposes only and not for use in humans or as food/feed unless authorization has been granted by the US Food and Drug Administration. In case of emergency release contact Exemplar Genetics at 712-722-2767 or 712-441-3408.

warning label

EXEGEN MYH7 MINISWINE 
pmyh7-blast excised not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-2003
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE (UNII: 0A87T8ALI3) (MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE - UNII:0A87T8ALI3) MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE1 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-2003-11 [arb'U] in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/15/2020
Labeler - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)
Registrant - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)
Establishment
NameAddressID/FEIBusiness Operations
Exemplar Genetics LLC (dba Precigen Exemplar)958331121manufacture

Revised: 4/2020
Document Id: 36daf457-5205-43cf-95c6-1365e1e36e46
Set id: f2282630-d79c-4606-8a3a-c513871b9953
Version: 2
Effective Time: 20200410
 
Exemplar Genetics LLC (dba Precigen Exemplar)