Galsulfase

Sold as Naglazyme. Every FDA application for this active ingredient.

As of Nov 14, 2026, FDA lists 1 application for Galsulfase (sold as Naglazyme), first approved May 31, 2005, with 3 new uses approved and 0 published complete response letters.

First approved: May 31, 2005
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $5.4M
First approved in the EU: Jan 23, 2006

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Naglazyme	Part D	$5.4M	+6%	0
Naglazyme	Part B	$0K	-100%	0

Approvals in the EU (EMA)

First approved in the EU 8 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Naglazyme, new substanceBioMarin International Limited · Jan 23, 2006

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders)MPS I, MPS II · University of California, San Francisco	Phase 1	Recruiting	Aug 31, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
May 31, 2005	NaglazymeBLA 125117 · New molecular entity	Biomarin	7	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA