EXEGEN MYH7 MINISWINE- pmyh7-blast excised not applicable

ExeGen MYH7 miniswine by

Drug Labeling and Warnings

ExeGen MYH7 miniswine by is a Other medication manufactured, distributed, or labeled by Exemplar Genetics, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

EXEGEN MYH7 MINISWINE 
pmyh7-blast excised not applicable

Product Information
Product Type		Item Code (Source)	NDC: 86093-2003
Route of Administration	NOT APPLICABLE

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86093-2003-1	1 [arb'U] in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/15/2020

Labeler - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)

Registrant - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)

Establishment
Name	Address	ID/FEI	Business Operations
Exemplar Genetics LLC (dba Precigen Exemplar)		958331121	manufacture