Food and Drug Administration

Endocronologic and Metobolic Drugs Advisory Committee

January 15, 2003

Briefing Information

Aldurazyme™ (Laronidase)

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Biologics License Application BL 128058, Biomarin Pharmaceuticals (PDF)

Aldurazyme™ (Laronidase) For the Treatment of Mucopolysaccharidosis I, Clinical Review, FDA (HTM) (PDF) (Word)

Aldurazyme™ (Laronidase) For the Treatment of Mucopolysaccharidosis I, Errata, FDA (HTM) (PDF) (Word)