# Semaglutide injection for weight management (Wegovy) Product · id `cardio:wegovy` · 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: Wegovy Browse, organ or system: Metabolism Browse, condition area: Diabetes and metabolic disease ## In plain language A prescription semaglutide injection given once a week, with a reduced-calorie diet and more physical activity. The FDA label record lists it to lower the risk of major heart and blood-vessel events in adults who have cardiovascular disease and obesity or overweight, and to reduce excess body weight and keep it off in adults and children aged 12 and older with obesity, and in adults with overweight who have at least one weight-related condition. The SELECT trial tested semaglutide 2.4 mg a week in adults with heart disease and overweight or obesity but no diabetes. ## Technical summary FDA application NDA215256, applicant listed as NOVO. Original approval on 2021-06-04 (ORIG-1, classified Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated). Dosage form SOLUTION. The label record used for the indications is a repackager copy (A-S Medication Solutions, effective 2024-04-23). ## 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 Wegovy (semaglutide injection) on 4 June 2021 under new drug application NDA215256. The Drugs@FDA page lists the original submission as ORIG-1, an approval. The openFDA record lists the applicant as NOVO and classifies the original submission as Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated. The label record fetched on 2026-10-14 says Wegovy is a GLP-1 receptor agonist indicated, with a reduced calorie diet and more physical activity, to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, and to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight who have at least one weight-related comorbid condition. 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 2021 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, effective 2024-04-23, and may not show later changes to the label. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA215256 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 2026-10-14T18:24:49Z. Source state: Current. Snapshot hash: af5056161789a8ea657eb7eb0e9dbbf6e7861d7cbf0105645ba18fe4c9f107df. How it applies: Application number and applicant. 2. Supports: Drugs@FDA: approval date(s) and history for NDA 215256 (Wegovy) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14.) Locator: Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY). Retrieved 2026-10-14T18:24:53Z. Source state: Current. Snapshot hash: e264a6cd297aa6eaa33269a0088d41fae8c6832dba56aa338817b23d4e2bb432. How it applies: Original approval date. 3. Supports: FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA215256 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\[3\].submission\_type; results\[0\].submissions\[3\].submission\_status; results\[0\].submissions\[3\].submission\_class\_code\_description. Retrieved 2026-10-14T18:24:49Z. Source state: Current. Snapshot hash: af5056161789a8ea657eb7eb0e9dbbf6e7861d7cbf0105645ba18fe4c9f107df. How it applies: Original submission, its status and classification. 4. Supports: WEGOVY drug label (openFDA record, set id f5e548d0-cc79-4c34-a3f5-e20a5b8b6564) (Label, edition openFDA drug label record, label effective 20240423, 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: a08bc72d365699317453205cf6fb34b92fc52711315bcba269f256581a5f8fc9. How it applies: Indications and dosing on the label record. 5. Background: FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA215256 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 2026-10-14T18:24:49Z. Source state: Current. Snapshot hash: af5056161789a8ea657eb7eb0e9dbbf6e7861d7cbf0105645ba18fe4c9f107df. How it applies: Active ingredient on the application record. 6. Background: WEGOVY drug label (openFDA record, set id f5e548d0-cc79-4c34-a3f5-e20a5b8b6564) (Label, edition openFDA drug label record, label effective 20240423, 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: a08bc72d365699317453205cf6fb34b92fc52711315bcba269f256581a5f8fc9. How it applies: The label record is a repackager listing. 7. Background: Drugs@FDA: approval date(s) and history for NDA 215256 (Wegovy) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14.) Locator: Supplements, Submission Classification. Retrieved 2026-10-14T18:24:53Z. Source state: Current. Snapshot hash: e264a6cd297aa6eaa33269a0088d41fae8c6832dba56aa338817b23d4e2bb432. 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-nda215256` - Product: Semaglutide injection for weight management (Wegovy) (`cardio:wegovy`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2021-06-04 - Product version: Wegovy (semaglutide) injection, application NDA215256, original submission ORIG-1 - Pathway: NDA - Submission: NDA215256 - Indication: The indication on the original approval was not read. On the current label record (repackager copy, 2024-04-23) the weight indication is limited to adults and pediatric patients aged 12 years and older with obesity, and adults with overweight in the presence of at least one weight-related comorbid condition; the other uses are in claim-fda-nda215256-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-nda215256-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 record for this application number gives 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`) - Investigated in: SELECT: semaglutide and cardiovascular outcomes in overweight or obesity (`cardio:select-trial`) ## Provenance Content hash: 330106f493a69f45fa873eead9c3bfdd7ff9b1f80ce3522487b025fa42476b03 Last substantive edit: 2026-10-14 Evidence last checked: Not recorded