Semaglutide injection for diabetes (Ozempic)

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 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.

  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 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

  Next evidence check due

  Not scheduled

  Sources and citations (7)

  1. Supports FDA New Drug Application NDA209637: Ozempic (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA209637

     Locator

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

     How it applies

     Application number and applicant.

     Retrieved

     2026-10-14T18:24:48Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     9bd57e08f426432cf5cc5c8d2af3f2faa892d4dc3214dd65c5fe5a7340f9ea48

     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-nda209637.json.

  2. Supports Drugs@FDA: approval date(s) and history for NDA 209637 (Ozempic)

     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

     2026-10-14T18:24:48Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     18ec128dd2136ba0ad76399b34d9681ca76ca06b861e208bf92efbaf6faab302

     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-nda209637.html.

  3. Supports FDA New Drug Application NDA209637: Ozempic (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA209637

     Locator

     results[0].submissions[1].submission_type; results[0].submissions[1].submission_status; results[0].submissions[1].submission_class_code_description

     How it applies

     Original submission, its status and classification.

     Retrieved

     2026-10-14T18:24:48Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     9bd57e08f426432cf5cc5c8d2af3f2faa892d4dc3214dd65c5fe5a7340f9ea48

     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-nda209637.json.

  4. Supports Ozempic drug label (openFDA record, set id 42bdd912-2393-44c4-b7e0-47672ca28991)

     Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · 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. · SPL set id: 42bdd912-2393-44c4-b7e0-47672ca28991

     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

     2026-07-30

     Source state

     Current

     Snapshot hash

     8584f7d2f847ec4bc9b5c9de6a74bd012fe46f45201158a5cc275af69084b07f

     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-42bdd912-2393-44c4-b7e0-47672ca28991.json.

  5. Background FDA New Drug Application NDA209637: Ozempic (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA209637

     Locator

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

     How it applies

     Active ingredient on the application record.

     Retrieved

     2026-10-14T18:24:48Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     9bd57e08f426432cf5cc5c8d2af3f2faa892d4dc3214dd65c5fe5a7340f9ea48

     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-nda209637.json.

  6. Background Ozempic drug label (openFDA record, set id 42bdd912-2393-44c4-b7e0-47672ca28991)

     Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · 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. · SPL set id: 42bdd912-2393-44c4-b7e0-47672ca28991

     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

     2026-07-30

     Source state

     Current

     Snapshot hash

     8584f7d2f847ec4bc9b5c9de6a74bd012fe46f45201158a5cc275af69084b07f

     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-42bdd912-2393-44c4-b7e0-47672ca28991.json.

  7. Background Drugs@FDA: approval date(s) and history for NDA 209637 (Ozempic)

     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

     2026-10-14T18:24:48Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     18ec128dd2136ba0ad76399b34d9681ca76ca06b861e208bf92efbaf6faab302

     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-nda209637.html.