# Sacubitril/valsartan (Entresto) Product · id `cardio:entresto` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: Entresto; ENTRESTO Browse, organ or system: Heart Browse, condition area: Heart failure ## In plain language Entresto is the brand name of sacubitril and valsartan tablets, a combination medicine. The US FDA approved the application on 7 July 2015, with priority review. The FDA records fetched here do not say what the medicine was approved to treat in 2015. The trial that compared the combination with enalapril is on the sacubitril/valsartan page. ## Technical summary FDA application NDA207620. The openFDA record names NOVARTIS PHARMS CORP as the sponsor and lists three tablet strengths of sacubitril and valsartan. The openFDA record names Novartis Pharmaceuticals Corporation as a manufacturer, and this record links to the Novartis organization record. ## Claims, with the population each applies to ## Context: United States approval record NDA207620 for Entresto (sacubitril and valsartan) Recipient: Recipient not specified; Population: Not stated in the fetched FDA records. They name a product and a sponsor and give no intended population or indication for the original approval.; Care setting: Not stated in the FDA records; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the FDA records; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) ### The US Food and Drug Administration approved New Drug Application NDA207620 for ENTRESTO (sacubitril and valsartan) tablets on 7 July 2015. The openFDA record lists the original approval as submission ORIG-1, classified as a new molecular entity (Type 1) and a new combination (Type 4), with priority review. The openFDA record names NOVARTIS PHARMS CORP as the sponsor of the application. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Recipient not specified; Population: Not stated in the fetched FDA records. They name a product and a sponsor and give no intended population or indication for the original approval.; Care setting: Not stated in the FDA records; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the FDA records; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) - Limitations: This claim records the original approval and the fields the records give. The records fetched carry no indication text for the original approval, so the claim does not say what the medicine was approved to treat then. The openFDA record also lists later submissions, mostly supplements, and the fetched records do not say which of them changed the approved uses, including for heart failure. Current labelling was not read. An approval is not a finding about how well the medicine works. openFDA's own disclaimer says not to rely on it for decisions about medical care. - Last checked: 2026-10-14 - Sources: 1. Supports: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The application number of this record. 2. Supports: Drugs@FDA overview page for NDA 207620 (ENTRESTO) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14. It lists the original approval date as a month-first slash date.) Locator: Original Approvals or Tentative Approvals table, Action Date (MM/DD/YYYY). Retrieved 2026-10-14T18:27:10Z. Source state: Current. Snapshot hash: 35ae8de0fff5b33987257d70528490692262378ee410a36df965b92dc71f2db6. How it applies: Original approval date and submission ORIG-1. The page writes the date month first; it is used only for the date. 3. Supports: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].submissions\[2\].submission\_class\_code\_description. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The submission classification of the original approval. 4. Supports: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].submissions\[2\].review\_priority. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The review priority of the original approval. 5. Supports: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].submissions\[2\].submission\_status\_date. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The openFDA submission list gives the same original approval date in compact form. 6. Supports: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].sponsor\_name. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The application sponsor, as the record writes the name. 7. Supports: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The brand name. 8. Supports: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].products\[0\].active\_ingredients. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The active ingredients of the product. 9. Background: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].products\[0\].dosage\_form. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: The dosage form of the listed products. 10. Background: openFDA Drugs@FDA record for NDA207620: ENTRESTO (sacubitril and valsartan tablets) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text.) Locator: results\[0\].openfda.manufacturer\_name\[0\]. Retrieved 2026-10-14T18:20:05Z. Source state: Current. Snapshot hash: 05824ca4f9c5acfde1d04b93a8c18e177284db808416d8cf6093c328357ba736. How it applies: A manufacturer name in the openFDA block of the record. ## Guidance, authorization and access ### Regulatory decision `cardio:regdec-fda-nda207620` - Product: Sacubitril/valsartan (Entresto) (`cardio:entresto`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2015-07-07 - Product version: Entresto tablets (dosage form TABLET in the openFDA record) - Pathway: NDA - Submission: NDA207620 - Indication: Not stated in the fetched FDA records for the original approval - Jurisdictions: United States; note: United States - Applies to: Recipient: Recipient not specified; Population: Not stated in the fetched FDA records. They name a product and a sponsor and give no intended population or indication for the original approval.; Care setting: Not stated in the FDA records; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the FDA records; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) - Basis: claim `cardio:claim-fda-nda207620-approval` ## Connected pages - Active ingredient of Entresto: Sacubitril/valsartan (combination) (`cardio:sacubitril-valsartan`) - The openFDA record names Novartis Pharmaceuticals Corporation as a manufacturer; the application sponsor is NOVARTIS PHARMS CORP: Novartis (`cardio:novartis`) - Files under this front: Medicines (`cardio:front-medicines`) ## Provenance Content hash: 237aaf40e15a6c308e90e307fb70360a53baac1b1f261529cc752aebc01aadf8 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-14