PCSK9 Inhibitor [EPC] - N0000191731

Pharmacologic Code	N0000191731
Pharmacologic Name	PCSK9 Inhibitor
Pharmacologic Uses	PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor
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 12 products whose active ingredient are classified under the same pharmacologic class PCSK9 Inhibitor [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	0024-5901	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
	0024-5902	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
	0024-5903	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
	0024-5904	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
	55513-750	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Inc	ACTIVE
	55513-760	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Inc	ACTIVE
	61755-020	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Regeneron Pharmaceuticals, Inc.	ACTIVE
	61755-021	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Regeneron Pharmaceuticals, Inc.	ACTIVE
	72511-750	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Usa Inc.	ACTIVE
	72511-760	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Usa Inc.	ACTIVE
	72733-5901	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi Us Corporation	ACTIVE
	72733-5902	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi Us Corporation	ACTIVE