Antisense Oligonucleotide [EPC] - N0000191626

Pharmacologic Code	N0000191626
Pharmacologic Name	Antisense Oligonucleotide
Pharmacologic Uses	antisense oligonucleotide apolipoprotein B-100 synthesis inhibitor survival motor neuron-2 (SMN2)-directed antisense oligonucleotide transthyretin-directed antisense oligonucleotide
Pharmacologic Concept	Established Pharmacologic Classes - [EPC]
Pharmacologic Concept Description	An established pharmacologic class is a term or phrase that is scientifically valid and clinically meaningful according to the following definitions: A scientifically valid pharmacologic class is supported by documented and submitted empiric evidence showing that the drug's pharmacologic class is known, not theoretical, and relevant and specific to the indication. A clinically meaningful pharmacologic class term or phrase enhances the ability of professionals to understand physiologic effects related to the indication or to anticipate undesirable effects that may be associated with the drug or pharmacologic class.

The table contains 5 products whose active ingredient are classified under the same pharmacologic class Antisense Oligonucleotide [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	60923-227	Amondys 45	Non-Proprietary Name: Casimersen	Injection	Intravenous	Sarepta Therapeutics, Inc.	ACTIVE
	60923-284	Exondys 51	Non-Proprietary Name: Eteplirsen	Injection	Intravenous	Sarepta Therapeutics, Inc.	ACTIVE
	60923-363	Exondys 51	Non-Proprietary Name: Eteplirsen	Injection	Intravenous	Sarepta Therapeutics, Inc.	ACTIVE
	64406-058	Spinraza	Non-Proprietary Name: Nusinersen	Injection, Solution	Intrathecal	Biogen	ACTIVE
	72126-007	Tegsedi	Non-Proprietary Name: Inotersen	Injection, Solution	Subcutaneous	Akcea Therapeutics, Inc.	ACTIVE