Semaglutide injection for weight management (Wegovy)

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)

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Recipient not specified

  • 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.
  • Not stated in the FDA records
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA records
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory decision)

  Certainty method

  Not assessed

  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

  Next evidence check due

  Not scheduled

  Sources and citations (7)

  1. Supports FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA215256

     Locator

     results[0].application_number; results[0].sponsor_name

     How it applies

     Application number and applicant.

     Retrieved

     2026-10-14T18:24:49Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     af5056161789a8ea657eb7eb0e9dbbf6e7861d7cbf0105645ba18fe4c9f107df

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215256.json.

  2. Supports Drugs@FDA: approval date(s) and history for NDA 215256 (Wegovy)

     Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition Drugs@FDA application overview page fetched 2026-10-14.

     Locator

     Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY)

     How it applies

     Original approval date.

     Retrieved

     2026-10-14T18:24:53Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     e264a6cd297aa6eaa33269a0088d41fae8c6832dba56aa338817b23d4e2bb432

     Reuse basis

     The FDA website policies page (fetched 2026-10-14 as ch-fda-website-policies.html, sha256 59b7c8541753, hash only) says that, unless otherwise noted, the contents of the FDA website (www.fda.gov) are not copyrighted and are in the public domain. This page is on the accessdata.fda.gov host of FDA; the policy page names www.fda.gov only, so the terms for this host are unverified and the source is cite_only: facts are stated in the atlas's own words, with no quoted span. The raw page is committed at research/snapshots/ch-fda-daf-nda215256.html.

  3. Supports FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA215256

     Locator

     results[0].submissions[3].submission_type; results[0].submissions[3].submission_status; results[0].submissions[3].submission_class_code_description

     How it applies

     Original submission, its status and classification.

     Retrieved

     2026-10-14T18:24:49Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     af5056161789a8ea657eb7eb0e9dbbf6e7861d7cbf0105645ba18fe4c9f107df

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215256.json.

  4. Supports WEGOVY drug label (openFDA record, set id f5e548d0-cc79-4c34-a3f5-e20a5b8b6564)

     Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · 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. · SPL set id: f5e548d0-cc79-4c34-a3f5-e20a5b8b6564

     Locator

     results[0].indications_and_usage[0]; results[0].dosage_and_administration[0]

     How it applies

     Indications and dosing on the label record.

     Retrieved

     2026-10-14T18:27:50Z

     Source effective date

     2024-04-23

     Source state

     Current

     Snapshot hash

     a08bc72d365699317453205cf6fb34b92fc52711315bcba269f256581a5f8fc9

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/ch-openfda-label-f5e548d0-cc79-4c34-a3f5-e20a5b8b6564.json.

  5. Background FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA215256

     Locator

     results[0].products[0].active_ingredients[0].name

     How it applies

     Active ingredient on the application record.

     Retrieved

     2026-10-14T18:24:49Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     af5056161789a8ea657eb7eb0e9dbbf6e7861d7cbf0105645ba18fe4c9f107df

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215256.json.

  6. Background WEGOVY drug label (openFDA record, set id f5e548d0-cc79-4c34-a3f5-e20a5b8b6564)

     Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · 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. · SPL set id: f5e548d0-cc79-4c34-a3f5-e20a5b8b6564

     Locator

     results[0].openfda.manufacturer_name[0]

     How it applies

     The label record is a repackager listing.

     Retrieved

     2026-10-14T18:27:50Z

     Source effective date

     2024-04-23

     Source state

     Current

     Snapshot hash

     a08bc72d365699317453205cf6fb34b92fc52711315bcba269f256581a5f8fc9

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/ch-openfda-label-f5e548d0-cc79-4c34-a3f5-e20a5b8b6564.json.

  7. Background Drugs@FDA: approval date(s) and history for NDA 215256 (Wegovy)

     Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition Drugs@FDA application overview page fetched 2026-10-14.

     Locator

     Supplements, Submission Classification

     How it applies

     The Drugs@FDA page lists later supplements classified as new indications, so the current label may differ from the original approval.

     Retrieved

     2026-10-14T18:24:53Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     e264a6cd297aa6eaa33269a0088d41fae8c6832dba56aa338817b23d4e2bb432

     Reuse basis

     The FDA website policies page (fetched 2026-10-14 as ch-fda-website-policies.html, sha256 59b7c8541753, hash only) says that, unless otherwise noted, the contents of the FDA website (www.fda.gov) are not copyrighted and are in the public domain. This page is on the accessdata.fda.gov host of FDA; the policy page names www.fda.gov only, so the terms for this host are unverified and the source is cite_only: facts are stated in the atlas's own words, with no quoted span. The raw page is committed at research/snapshots/ch-fda-daf-nda215256.html.