Naglazyme Approval History
FDA Approved: Yes (First approved May 31, 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, 2005||Naglazyme BioMarin Pharmaceutical Inc. - Treatment for Mucopolysaccharidosis VI (MPS VI)|
|Nov 29, 2004||BioMarin Submits U.S. Biologics License Application for Marketing Authorization of Aryplase for MPS VI|
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