Krystexxa
These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA KRYSTEXXA (pegloticase) Injection, for intravenous infusion Initial U.S. Approval: 2010
Approved
Approval ID
5f4574d1-401f-4647-83e5-28c0f4a122a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2012
Manufacturers
FDA
Savient Pharmaceuticals, Inc.
DUNS: 101113025
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegloticase
PRODUCT DETAILS
NDC Product Code54396-801
Application NumberBLA125293
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2013
Generic Namepegloticase
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEGLOTICASEActive
Quantity: 8 mg in 1 mL
Code: R581OT55EA
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT