Claudin 18.2-directed Cytolytic Antibody [EPC] - N0000194107

Pharmacologic Code	N0000194107
Pharmacologic Name	Claudin 18.2-directed Cytolytic Antibody
Pharmacologic Uses	claudin 18.2-directed cytolytic antibody
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 2 products whose active ingredient are classified under the same pharmacologic class Claudin 18.2-directed Cytolytic Antibody [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	0469-3425	Vyloy	Non-Proprietary Name: Zolbetuximab	Injection, Powder, For Suspension	Intravenous	Astellas Pharma Us, Inc.	ACTIVE
	0469-4425	Vyloy	Non-Proprietary Name: Zolbetuximab	Injection, Powder, For Suspension	Intravenous	Astellas Pharma Us, Inc.	ACTIVE