ExeGen MYH7 miniswine

Manufacturer: Exemplar Genetics LLC (dba Precigen Exemplar)
Effective date: 2025-05-21
Label type: INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:51:39

Label at a glance#

ProductExeGen MYH7 miniswine

Active ingredientMYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE

Label structure1 sections

Contacts and useful links#

PhoneLabel contact712-722-2767

PhoneLabel contact712-441-3408

Label contents#

Full prescribing information#

ExeGen MYH7 miniswine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
86093-2003-1	ExeGen MYH7 miniswine	1 [arb'U] in 1 PACKAGE	NOT APPLICABLE	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
86093-2003	EXEGEN MYH7 MINISWINE (PMYH7-BLAST EXCISED) NOT APPLICABLE [EXEMPLAR GENETICS LLC (DBA PRECIGEN EXEMPLAR)]	3	1 package rows	20250523_f2282630-d79c-4606-8a3a-c513871b9953.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

ExeGen MYH7 miniswine
pMYH7-Blast Excised
MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
86093-2003	86093-2003-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MYH7 RDNA CONSTRUCT DISRUPTING EXON 13 OF MYH7 GENE IN YUCATAN MINIATURE SWINE	0A87T8ALI3	ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.