The committee will discuss supplemental new drug application (sNDA) 207620-S18, for the angiotensin receptor-neprilysin inhibitor, ENTRESTO (sacubitril and valsartan) tablets, submitted by Novartis Pharmaceuticals Corp., for the proposed indication of heart failure with preserved ejection fraction (HFpEF). [Docket FDA-2020-N-1330]
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Earlier Event: December 10
Vaccines and Related Biological Products Advisory Committee
Later Event: December 16
Cardiovascular and Renal Drugs Advisory Committee