# Semaglutide injection for diabetes (Ozempic) Product · id `cardio:ozempic` · 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: Ozempic Browse, organ or system: Metabolism Browse, condition area: Diabetes and metabolic disease ## In plain language A prescription semaglutide injection given once a week. The FDA label record lists it to improve blood sugar control in adults with type 2 diabetes, to lower the risk of major heart and blood-vessel events in adults who also have established cardiovascular disease, and to lower the risk of kidney decline, kidney failure and cardiovascular death in adults who also have chronic kidney disease. ## Technical summary FDA application NDA209637, applicant listed as NOVO. Original approval on 2017-12-05 (ORIG-1, Type 1 - New Molecular Entity). Dosage form SOLUTION. The label record used for the indications is a repackager copy (A-S Medication Solutions, effective 2026-07-30). ## Claims, with the population each applies to ## Context: United States FDA original approval of a new drug application (NDA) Recipient: Recipient not specified; Population: Not stated in the FDA application records read. The records give the applicant, the products and the submission history; the label record gives age limits for each indication.; 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 Ozempic (semaglutide injection) on 5 December 2017 under new drug application NDA209637. The Drugs@FDA page lists the original submission as ORIG-1, an approval, classified Type 1 - New Molecular Entity. The openFDA record lists the applicant as NOVO. The label record fetched on 2026-10-14 says Ozempic is a GLP-1 receptor agonist indicated to improve glycemic control in adults with type 2 diabetes, to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults who have both type 2 diabetes and chronic kidney disease. It is dosed once weekly. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Recipient not specified; Population: Not stated in the FDA application records read. The records give the applicant, the products and the submission history; the label record gives age limits for each indication.; 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: An FDA approval is a decision about a medicine, not a finding about how much it helps any person. The date comes from the Drugs@FDA page, which writes it as a month-first slash date. The openFDA record gives the date only as a compact number, so the page is quoted. The indications quoted are those on the label record fetched on 2026-10-14 and may differ from the original 2017 approval, which later supplements changed; the original indication is not in the sources read. openFDA says not to rely on it for decisions about medical care. The label record is a copy listed under the repackager A-S Medication Solutions, not Novo Nordisk; no label record from Novo Nordisk was found by the application-number search. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA New Drug Application NDA209637: Ozempic (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA209637 returned on 2026-10-14, from a dataset last updated 2026-10-13. It lists the applicant, products and submissions but gives the original approval date only as a compact number (YYYYMMDD), so the Drugs@FDA page is also kept as a snapshot.) Locator: results\[0\].application\_number; results\[0\].sponsor\_name. Retrieved 2026-10-14T18:24:48Z. Source state: Current. Snapshot hash: 9bd57e08f426432cf5cc5c8d2af3f2faa892d4dc3214dd65c5fe5a7340f9ea48. How it applies: Application number and applicant. 2. Supports: Drugs@FDA: approval date(s) and history for NDA 209637 (Ozempic) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14.) Locator: Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY). Retrieved 2026-10-14T18:24:48Z. Source state: Current. Snapshot hash: 18ec128dd2136ba0ad76399b34d9681ca76ca06b861e208bf92efbaf6faab302. How it applies: Original approval date. 3. Supports: FDA New Drug Application NDA209637: Ozempic (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA209637 returned on 2026-10-14, from a dataset last updated 2026-10-13. It lists the applicant, products and submissions but gives the original approval date only as a compact number (YYYYMMDD), so the Drugs@FDA page is also kept as a snapshot.) Locator: results\[0\].submissions\[1\].submission\_type; results\[0\].submissions\[1\].submission\_status; results\[0\].submissions\[1\].submission\_class\_code\_description. Retrieved 2026-10-14T18:24:48Z. Source state: Current. Snapshot hash: 9bd57e08f426432cf5cc5c8d2af3f2faa892d4dc3214dd65c5fe5a7340f9ea48. How it applies: Original submission, its status and classification. 4. Supports: Ozempic drug label (openFDA record, set id 42bdd912-2393-44c4-b7e0-47672ca28991) (Label, edition openFDA drug label record, label effective 20260730, dataset last updated 2026-10-13. This label record is the one openFDA returned for the application number; its manufacturer field names A-S Medication Solutions, a repackager. The labeling text is the product labeling for the application; no label record from Novo Nordisk itself was found by the application-number search.) Locator: results\[0\].indications\_and\_usage\[0\]; results\[0\].dosage\_and\_administration\[0\]. Retrieved 2026-10-14T18:27:50Z. Source state: Current. Snapshot hash: 8584f7d2f847ec4bc9b5c9de6a74bd012fe46f45201158a5cc275af69084b07f. How it applies: Indications and dosing on the label record. 5. Background: FDA New Drug Application NDA209637: Ozempic (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA209637 returned on 2026-10-14, from a dataset last updated 2026-10-13. It lists the applicant, products and submissions but gives the original approval date only as a compact number (YYYYMMDD), so the Drugs@FDA page is also kept as a snapshot.) Locator: results\[0\].products\[0\].active\_ingredients\[0\].name. Retrieved 2026-10-14T18:24:48Z. Source state: Current. Snapshot hash: 9bd57e08f426432cf5cc5c8d2af3f2faa892d4dc3214dd65c5fe5a7340f9ea48. How it applies: Active ingredient on the application record. 6. Background: Ozempic drug label (openFDA record, set id 42bdd912-2393-44c4-b7e0-47672ca28991) (Label, edition openFDA drug label record, label effective 20260730, dataset last updated 2026-10-13. This label record is the one openFDA returned for the application number; its manufacturer field names A-S Medication Solutions, a repackager. The labeling text is the product labeling for the application; no label record from Novo Nordisk itself was found by the application-number search.) Locator: results\[0\].openfda.manufacturer\_name\[0\]. Retrieved 2026-10-14T18:27:50Z. Source state: Current. Snapshot hash: 8584f7d2f847ec4bc9b5c9de6a74bd012fe46f45201158a5cc275af69084b07f. How it applies: The label record is a repackager listing. 7. Background: Drugs@FDA: approval date(s) and history for NDA 209637 (Ozempic) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14.) Locator: Supplements, Submission Classification. Retrieved 2026-10-14T18:24:48Z. Source state: Current. Snapshot hash: 18ec128dd2136ba0ad76399b34d9681ca76ca06b861e208bf92efbaf6faab302. How it applies: The Drugs@FDA page lists later supplements classified as new indications, so the current label may differ from the original approval. ## Guidance, authorization and access ### Regulatory decision `cardio:regdec-fda-nda209637` - Product: Semaglutide injection for diabetes (Ozempic) (`cardio:ozempic`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2017-12-05 - Product version: Ozempic (semaglutide) injection, application NDA209637, original submission ORIG-1 - Pathway: NDA - Submission: NDA209637 - Indication: The indication on the original approval was not read. The uses on the current label record are in claim-fda-nda209637-approval. - Jurisdictions: United States; note: United States - Applies to: Recipient: Recipient not specified; Population: Not stated in the FDA application records read. The records give the applicant, the products and the submission history; the label record gives age limits for each indication.; 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-nda209637-approval` ## Connected pages - Active ingredient on the openFDA application record: Semaglutide (`cardio:semaglutide`) - Applicant (listed as NOVO) on the openFDA application record. openFDA's drug label records for this application number give A-S Medication Solutions in the manufacturer name field, not Novo Nordisk, as of 2026-10-15: Novo Nordisk (`cardio:novo-nordisk`) - Filed under this front: Medicines (`cardio:front-medicines`) ## Provenance Content hash: 7a293adc16e82d83890663c0f37f140cdd5042dbbe364293ea3979e0163caa1c Last substantive edit: 2026-10-14 Evidence last checked: Not recorded