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Naglazyme Approval History

  • FDA approved: Yes (First approved May 31st, 2005)
  • Brand name: Naglazyme
  • Generic name: galsulfase
  • Previous name: Aryplase
  • Company: BioMarin Pharmaceutical Inc.
  • Treatment for: Mucopolysaccharidosis Type VI

Naglazyme (galsulfase) is an enzyme-replacement therapy for treatment of mucopolysaccharidosis VI (MPS VI), an inherited, life-threatening lysosomal storage disorder caused by a deficiency of the lysosomal enzyme N-acetylgalactosamine 4-sulfatase (also known as arylsulfatase B).

Development History and FDA Approval Process for Naglazyme

May 31, 2005Approval Naglazyme BioMarin Pharmaceutical Inc. - Treatment for Mucopolysaccharidosis VI (MPS VI)
Nov 29, 2004BioMarin Submits U.S. Biologics License Application for Marketing Authorization of Aryplase for MPS VI

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