KANUMA
These highlights do not include all the information needed to use KANUMA safely and effectively. See full prescribing information for KANUMA. KANUMA (sebelipase alfa) injection, for intravenous use Initial U.S. Approval: 2015
Approved
Approval ID
83a77b9d-42f0-4645-8420-786285da7326
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 18, 2023
Manufacturers
FDA
Alexion Pharmaceuticals, Inc.
DUNS: 789359510
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sebelipase alfa
PRODUCT DETAILS
NDC Product Code25682-007
Application NumberBLA125561
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateNovember 24, 2021
Generic NameSebelipase alfa
INGREDIENTS (4)
Sebelipase alfaActive
Quantity: 2 mg in 1 mL
Code: K4YTU42T8G
Classification: ACTIB
Trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
Citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Albumin HumanInactive
Code: ZIF514RVZR
Classification: IACT