Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] - N0000175823

Name: Table of NDC products with hydrolytic lysosomal glycosaminoglycan-specific enzyme
Creator: U.S. Food & Drug Administration
License: https://creativecommons.org/licenses/by-nc-sa/4.0/

Pharmacologic Class Information

Pharmacologic Code	N0000175823
Pharmacologic Name	Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
Pharmacologic Uses	hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
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.

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NDC Products with Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

The following table contains 4 products whose active ingredient are classified under the same pharmacologic class Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC].

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
54092-700	Elaprase	Non-Proprietary Name: Idursulfase	Solution, Concentrate	Intravenous	Takeda Pharmaceuticals America, Inc.	ACTIVE
58468-0070	Aldurazyme	Non-Proprietary Name: Laronidase	Injection, Solution, Concentrate	Intravenous	Genzyme Corporation	ACTIVE
68135-020	Naglazyme	Non-Proprietary Name: Galsulfase	Solution	Intravenous	Biomarin Pharmaceutical Inc.	ACTIVE
68135-100	Vimizim	Non-Proprietary Name: Elosulfase Alfa	Injection, Solution, Concentrate	Intravenous	Biomarin Pharmaceutical Inc.	ACTIVE