AMVUTTRA
These highlights do not include all the information needed to use AMVUTTRA™ safely and effectively. See full prescribing information for AMVUTTRA. AMVUTTRA (vutrisiran) injection, for subcutaneous use Initial U.S. Approval: 2022
Approved
Approval ID
8db0facb-81b6-4006-9239-27dc6409c5d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2023
Manufacturers
FDA
Alnylam Pharmaceuticals, Inc.
DUNS: 115524410
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VUTRISIRAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71336-1003
Application NumberNDA215515
Product Classification
M
Marketing Category
C73594
G
Generic Name
VUTRISIRAN
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (7)
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
VUTRISIRANActive
Quantity: 25 mg in 0.5 mL
Code: GB4I2JI8UI
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
Phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT