Entresto fda approval history?

When did the FDA approve Entresto (sacubitril/valsartan)?

Entresto (sacubitril/valsartan) received FDA approval on July 7, 2015. [1]

What FDA approval was Entresto first granted for in 2015?

The initial FDA approval covered treatment of heart failure with reduced ejection fraction (HFrEF) in patients meeting guideline-supported criteria, as reflected in the FDA labeling associated with that approval. [1]

Was Entresto’s FDA approval expanded after the initial approval?

Yes. Entresto later received additional FDA approval for heart failure with preserved ejection fraction (HFpEF), which the FDA approved in 2021. [1][2]

What applications/indications are reflected in the FDA label over time?

Across its FDA approvals, Entresto’s label history reflects expansion from an initial HFrEF indication (2015) to later approval for HFpEF (2021). [1][2]

Where can I verify the approval dates and label history?

You can verify the approval dates and related labeling through the FDA’s product page and associated labeling documents for Entresto. [1]

Sources

1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207620
   
2. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-treatment-heart-failure-preserved-ejection-fraction