Tegsedi
These highlights do not include all the information needed to use TEGSEDI safely and effectively. See full prescribing information for TEGSEDI. TEGSEDI (inotersen) injection, for subcutaneous use Initial U.S. Approval: 2018
Approved
Approval ID
8513207e-b55f-417b-9473-af785146a543
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Akcea Therapeutics, Inc.
DUNS: 079911419
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
inotersen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72126-007
Application NumberNDA211172
Product Classification
M
Marketing Category
C73594
G
Generic Name
inotersen
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 20, 2019
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
INOTERSEN SODIUMActive
Quantity: 284 mg in 1.5 mL
Code: 950736UC77
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT