KYNAMRO- mipomersen sodium injection, solution

Kynamro by

Drug Labeling and Warnings

Kynamro by is a Prescription medication manufactured, distributed, or labeled by Kastle Therapeutics, LLC, Genzyme Corporation, Genzyme Haverhill, International Laboratory Services, Ltd, Ionis Pharmaceuticals Inc., PCI Pharma Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

KYNAMRO- MIPOMERSEN SODIUM INJECTION, SOLUTION

Principal Display Panel

INGREDIENTS AND APPEARANCE

KYNAMRO 
mipomersen sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70688-0502
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MIPOMERSEN SODIUM (UNII: 18EAY4870E) (MIPOMERSEN - UNII:9GJ8S4GU0M)	MIPOMERSEN SODIUM	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70688-0502-1	1 in 1 CARTON	05/02/2016
1		1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 70688-0502-2	4 in 1 CARTON	05/02/2016
2		1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA203568	05/02/2016

Labeler - Kastle Therapeutics, LLC (080134022)

Establishment
Name	Address	ID/FEI	Business Operations
Genzyme Corporation		098066215	MANUFACTURE(70688-0502) , ANALYSIS(70688-0502) , PACK(70688-0502) , LABEL(70688-0502)

Establishment
Name	Address	ID/FEI	Business Operations
Genzyme Haverhill		229522842	PACK(70688-0502) , ANALYSIS(70688-0502) , LABEL(70688-0502)

Establishment
Name	Address	ID/FEI	Business Operations
International Laboratory Services, Ltd		777381963	STERILIZE(70688-0502)

Establishment
Name	Address	ID/FEI	Business Operations
Ionis Pharmaceuticals Inc.		011829916	API MANUFACTURE(70688-0502) , ANALYSIS(70688-0502)

Establishment
Name	Address	ID/FEI	Business Operations
PCI Pharma Services		053217022	LABEL(70688-0502) , PACK(70688-0502)