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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the January 13, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

 

FDA

Disclaimer

 

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- CARBAGLU (carglumic acid) Tablets Briefing Material (pdf)

 

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Orphan Europe, SARL

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.

 

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

 

Orphan Europe- CARBAGLU (carglumic acid) Tablets Briefing Material (pdf)

 

Orphan Europe- CARBAGLU (carglumic acid) Tablets Appendix 1 (pdf)

 

Orphan Europe- CARBAGLU (carglumic acid) Tablets Appendix 2 (pdf)