Enzyme Stabilizer [EPC] - N0000194077

Pharmacologic Code	N0000194077
Pharmacologic Name	Enzyme Stabilizer
Pharmacologic Uses	enzyme stabilizer glucosylceramide synthase 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 5 products whose active ingredient are classified under the same pharmacologic class Enzyme Stabilizer [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	42799-709	Yargesa	Non-Proprietary Name: Miglustat	Capsule	Oral	Edenbridge Pharmaceuticals Llc.	ACTIVE
	43975-310	Miglustat	Non-Proprietary Name: Miglustat	Capsule	Oral	Ani Pharmaceuticals, Inc.	ACTIVE
	68475-204	Miglustat	Non-Proprietary Name: Miglustat	Capsule	Oral	Navinta Llc	ACTIVE
	70710-2039	Miglustat	Non-Proprietary Name: Miglustat	Capsule	Oral	Zydus Pharmaceuticals Usa Inc.	ACTIVE
	71904-300	Opfolda	Non-Proprietary Name: Miglustat	Capsule	Oral	Amicus Therapeutics Us, Llc	ACTIVE