CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

October 11, 2001

NDA 20-665/S-016 and NDA 21-283/S-001 Diovan (valsartan) Capsules and Tablets for the treatment of patients with heart failure

Novartis Pharmaceuticals Corporation

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.

Briefing Information   pdf

Food and Drug Administration

Clinical Pharmacology and Biopharmaceutics Review   pdf   doc
[Note:  If you are unable to read the tables in the word version, all tables are present in the pdf version. ]

Medical-Statistical Review   pdf   doc