Purple Book product · Reference 351(a)
Naglazyme
galsulfase
May 31, 2005
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
May 31, 2005
21 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 31, 2012
14 yr 4 mo ago
Today
Pharmaceutical detail
Strength
5MG/5ML (1MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1649
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Naglazyme have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Naglazyme are listed in the FDA Purple Book yet.
What is Naglazyme's BLA number?
Naglazyme is licensed under BLA 125117, held by BioMarin Pharmaceutical Inc..
When was Naglazyme approved by the FDA?
Naglazyme was approved by the FDA on May 31, 2005.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
