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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the January 12, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee





Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).


FDA- ZAVESCA (miglustat) Capsules Briefing Material (pdf)

FDA- ZAVESCA (miglustat) Capsules Errata (pdf)




Actelion Pharmaceuticals Ltd



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.


Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance


Actelion- ZAVESCA (miglustat) Capsules Briefing Material (pdf)