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