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VYJUVEK

These highlights do not include all the information needed to use VYJUVEK safely and effectively. See full prescribing information for VYJUVEK. VYJUVEK™ (beremagene geperpavec-svdt) biological suspension mixed with excipient gel for topical applicationInitial U.S. Approval: 2023

Approved
Approval ID

fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 1, 2023

Manufacturers
FDA

Krystal Biotech, Inc.

DUNS: 021814762

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VYJUVEK

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82194-510
Application NumberBLA125774
Product Classification
M
Marketing Category
C73585
G
Generic Name
VYJUVEK
Product Specifications
Effective DateJuly 1, 2023
FDA Product Classification

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VYJUVEK - FDA Drug Approval Details