Nexviazyme
These highlights do not include all the information needed to use NEXVIAZYME safely and effectively. See full prescribing information for NEXVIAZYME. NEXVIAZYME (avalglucosidase alfa-ngpt) for injection, for intravenous use Initial U.S. Approval: 2021
Approved
Approval ID
80eb3c9c-01d3-44fe-90ef-81df101b954d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
avalglucosidase alfa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0426
Application NumberBLA761194
Product Classification
M
Marketing Category
C73585
G
Generic Name
avalglucosidase alfa
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 26, 2023
FDA Product Classification
INGREDIENTS (6)
AVALGLUCOSIDASE ALFAActive
Quantity: 100 mg in 10 mL
Code: EO144CP0X9
Classification: ACTIB
HISTIDINEInactive
Quantity: 10.7 mg in 10 mL
Code: 4QD397987E
Classification: IACT
GLYCINEInactive
Quantity: 200 mg in 10 mL
Code: TE7660XO1C
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 6.5 mg in 10 mL
Code: X573657P6P
Classification: IACT
MANNITOLInactive
Quantity: 200 mg in 10 mL
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 1 mg in 10 mL
Code: 6OZP39ZG8H
Classification: IACT