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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: avalglucosidase alfa-ngpt
Trade Name: Nexviazyme
Date Designated: 11/19/2013
Orphan Designation: Treatment of Pompe Disease
Orphan Designation Status: Designated/Approved
Genzyme Corporation, a Sanofi Company
50 Binney Street
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: avalglucosidase alfa-ngpt
Trade Name: Nexviazyme
Marketing Approval Date: 08/06/2021
Approved Labeled Indication: Treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency)
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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