FDA.reportPublic FDA data

Application 761194

Type
BLA
Sponsor
GENZYME CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761194Nexviazymeavalglucosidase alfa-ngpt351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEXVIAZYMEAVALGLUCOSIDASE ALFA-NGPTINJECTABLE;INJECTION100MGNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NexviazymeAVALGLUCOSIDASE ALFA-NGPTGenzyme Corporation80eb3c9c-01d3-44fe-90ef-81df101b954d2025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761194
ndc (product): 58468-0426

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0426Nexviazymeavalglucosidase alfaGenzyme CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75509SUPPL 2023-09-18
75501SUPPL 2023-09-18
68549ORIG2021-09-07
68329ORIG2021-08-10
68317ORIG2021-08-09