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Cardiovascular and Renal Drugs Advisory Committee
June 25, 2008
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).
Combined Clinical and Statistical Review (pdf)
FDA Review of Patient-Reported Outcome (PRO) Measures for the Hyponatremia Indication (pdf)
Pharmacometric Review (pdf)
Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Briefing Material (pdf)