{ "release_id": "5dcd9b263fe17744", "id": "cardio:wegovy", "owner": "cardio", "kind": "product", "slug": "wegovy", "name": "Semaglutide injection for weight management (Wegovy)", "aliases": [ "Wegovy" ], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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).", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": null, "next_review_due": null, "identifiers": [], "navigation": { "cardio": { "system": [ "metabolism" ], "condition-area": [ "diabetes-and-metabolic-disease" ] } }, "payload": { "subtype": "medicine", "model_or_formulation": "Solution for subcutaneous injection (dosage form SOLUTION on the openFDA record); several strengths.", "version": "Not stated in the sources read. The application covers several strengths and presentations.", "intended_use_snapshots": [ "cardio:openfda-label-f5e548d0-cc79-4c34-a3f5-e20a5b8b6564-2026-10-14" ] }, "content_digest": "330106f493a69f45fa873eead9c3bfdd7ff9b1f80ce3522487b025fa42476b03", "review": { "content_digest": "330106f493a69f45fa873eead9c3bfdd7ff9b1f80ce3522487b025fa42476b03", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "5dcd9b263fe17744", "id": "cardio:claim-fda-nda215256-approval", "owner": "cardio", "subject_entity_id": "cardio:wegovy", "category": "regulatory", "statement": "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.", "context": { "id": "cardio:ctx-fda-us-nda-approval-record", "label": "United States FDA original approval of a new drug application (NDA)", "recipient": "unknown", "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_note": "Not stated in the FDA records", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision)", "eligibility": { "inclusion": [], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].application_number; results[0].sponsor_name", "applicability_note": "Application number and applicant.", "snapshot": { "id": "cardio:openfda-nda215256-2026-10-14", "retrieved_at": "2026-10-14T18:24:49Z", "content_hash": "af5056161789a8ea657eb7eb0e9dbbf6e7861d7cbf0105645ba18fe4c9f107df", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-nda215256", "source_type": "regulator", "title": "FDA New Drug Application NDA215256: Wegovy (openFDA drugsfda record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215256", "identifiers": [ { "scheme": "fda-nda", "value": "NDA215256", "normalized_value": "NDA215256", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "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. 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The raw record is committed at research/snapshots/ch-openfda-nda215256.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY)", "applicability_note": "Original approval date.", "snapshot": { "id": "cardio:fda-daf-nda215256-2026-10-14", "retrieved_at": "2026-10-14T18:24:53Z", "content_hash": "e264a6cd297aa6eaa33269a0088d41fae8c6832dba56aa338817b23d4e2bb432", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-daf-nda215256", "source_type": "regulator", "title": "Drugs@FDA: approval date(s) and history for NDA 215256 (Wegovy)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215256", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (Drugs@FDA)", "edition": "Drugs@FDA application overview page fetched 2026-10-14.", "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. 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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.", "public_text": "cite_only" } } ], "review": { "content_digest": "038c45fec3aa61d91306d7dd68565aa1631624fd2c2804a7935987f2ee7167e7", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-nda215256-approval.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "cardio:regdec-fda-nda215256", "product_id": "cardio:wegovy", "product_version": "Wegovy (semaglutide) injection, application NDA215256, original submission ORIG-1", "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.", "context_id": "cardio:ctx-fda-us-nda-approval-record", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "approval", "recall_class": null, "submission_id": "NDA215256", "pathway": "nda", "product_code": null, "device_class": null, "decision_date": "2021-06-04", "valid_to": null, "claim_id": "cardio:claim-fda-nda215256-approval" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "contains", "label": "Active ingredient on the openFDA application record", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "cardio:semaglutide", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "cardio:openfda-nda215256-2026-10-14", "locator": "results[0].products[0].active_ingredients[0].name" }, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "manufactured_by", "label": "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", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "cardio:novo-nordisk", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "cardio:openfda-nda215256-2026-10-14", "locator": "results[0].sponsor_name" }, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "part_of", "label": "Filed under this front", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "cardio:front-medicines", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [ { "predicate": "investigates", "label": "Investigated in", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "cardio:select-trial", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "cardio:openfda-label-f5e548d0-cc79-4c34-a3f5-e20a5b8b6564-2026-10-14", "locator": "results[0].clinical_studies[0]" }, "primary": false, "role": null, "valid_from": null, "valid_to": null } ] }, "page_path": "products/wegovy/", "context_path": "api/v1/context/cardio--wegovy.md" }