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Company BioMarin / Original Submission BioMarin Pharmaceuticals Incorporated / DCTDA / / Country Northern Ireland / / Event Product Issues / / Facility Laboratory Abnormalities / / IndustryTerm drug product / recombinant enzyme product / liquid solution / lysosomal degradation products / / MedicalCondition Hurler syndrome / endocardial fibroelastosis / valvular heart disease / hydrocephalus / Mucopolysaccharidosis / This disorder / disease / Lysosomal storage disorders / acute cardiomyopathy / ear infections / progressive disorder / Hurler-Scheie Syndrome / mucolipidoses / macroglossia / noisy breathing / umbilical hernias / respiratory infections / Apnea / sinus infections / aortic valve disease / pulmonary hypertension / Scheie Syndrome / skeletal deformities / severe hydrocephalus / milder disease / Mucopolysaccharidosis I / enzymatic deficiency / dysostosis / obstructive airway disease / deafness / gangliosidoses / sleep apnea / iduronidase deficiency / lysosomal storage diseases / intellectual dysfunction / deficiency / Eye disease / Clinical Background Lysosomal storage disorders / / MedicalTreatment enzyme replacement therapy / nasal continuous positive airway pressure / intravenous infusion / / Organization Memorandum Division of Clinical Trial Design / FDA / HUMAN SERVICES Public Health Service Food and Drug Administration Center / DEPARTMENT OF HEALTH / / Person Marc K. Walton / Ilan Irony / Dwaine Rieves / Pike Rockville / / Position Team Leader / Investigator Global Assessment / Medical Officer / Acting Deputy Director / / Product ALDURAZYME / enzyme / / ProvinceOrState Maryland / / Technology Pharmacokinetics / 81 Protocol / 15 Protocol / 40 Protocol / cloning / 85 Protocol / 21 Protocol / transplantation / 21 Formal Protocol / genotype / 34 Protocol / / URL www.genome.ad.jp/dbget-bin/get_pathway?org_name=hsa&mapno=00531 / / SocialTag 
Review - Laronidase (Aldurazyme)