VABYSMO
These highlights do not include all the information needed to use VABYSMO safely and effectively. See full prescribing information for VABYSMO. VABYSMO (faricimab-svoa) injection, for intravitreal use Initial U.S. Approval: 2022
Approved
Approval ID
04cc9ef7-c02a-4e92-a655-0062674e8487
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Faricimab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-096
Application NumberBLA761235
Product Classification
M
Marketing Category
C73585
G
Generic Name
Faricimab
Product Specifications
Route of AdministrationINTRAVITREAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (8)
FARICIMABActive
Quantity: 6 mg in 0.05 mL
Code: QC4F7FKK7I
Classification: ACTIB
POLYSORBATE 20Inactive
Quantity: 20 ug in 0.05 mL
Code: 7T1F30V5YH
Classification: IACT
HISTIDINEInactive
Quantity: 155 ug in 0.05 mL
Code: 4QD397987E
Classification: IACT
METHIONINEInactive
Quantity: 52.2 ug in 0.05 mL
Code: AE28F7PNPL
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 73.1 ug in 0.05 mL
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Quantity: 2.74 mg in 0.05 mL
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT