{"answer":{"query":"Aimovig","resolved_as":"applications","packages":6,"applications":["BLA761077"],"identity":{"application_numbers":["BLA761077"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true},{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2018-05-22","latest":"2019-03-15","packages_with_a_start_date":6}},"label_history":{"events_total":13,"non_cmc_events":12,"counts_by_class":{"LABELING":10,"EFFICACY":2},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA761077","submission_no":25,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-19","documents":[{"type":"Letter","date":"2025-06-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761077Orig1s025ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761077Orig1s025lbl.pdf","untrusted":true}}],"fact_id":"39413032d9cefc7d8f121c8b"},{"application":"BLA761077","submission_no":26,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-21","documents":[{"type":"Label","date":"2025-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761077s026lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761077Orig1s026ltr.pdf","untrusted":true}}],"fact_id":"4913c2853e5ddacd1c49e32a"},{"application":"BLA761077","submission_no":22,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-06","documents":[{"type":"Letter","date":"2024-08-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761077Orig1s022ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761077s022lbl.pdf","untrusted":true}}],"fact_id":"aea90ffcab1bb0cc22b59800"},{"application":"BLA761077","submission_no":15,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-10-03","documents":[{"type":"Letter","date":"2022-10-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761077Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-10-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761077s015lbl.pdf","untrusted":true}}],"fact_id":"5b88a30c11105cd0e103ec15"},{"application":"BLA761077","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-09-22","documents":[{"type":"Letter","date":"2022-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761077Orig1s017Correctedltr.pdf","untrusted":true}},{"type":"Label","date":"2022-09-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761077Orig1s017Correctedlbl.pdf","untrusted":true}}],"fact_id":"837f39f517c339f89d9ec8a0"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"meaning":"raw FDA codes; 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Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"decf2d5acac4689e4ed0ca3a","field":"ndc.listing","entity":"ndc:55513084001"},{"fact_id":"7edfbd86cae66dbd401dc59e","field":"ndc.listing","entity":"ndc:55513084100"},{"fact_id":"ad1b3ea9b8c6981bf0d2d3d8","field":"ndc.listing","entity":"ndc:55513084101"},{"fact_id":"39413032d9cefc7d8f121c8b","field":"drug.label_event","entity":"application:BLA761077"},{"fact_id":"4913c2853e5ddacd1c49e32a","field":"drug.label_event","entity":"application:BLA761077"},{"fact_id":"aea90ffcab1bb0cc22b59800","field":"drug.label_event","entity":"application:BLA761077"},{"fact_id":"5b88a30c11105cd0e103ec15","field":"drug.label_event","entity":"application:BLA761077"},{"fact_id":"837f39f517c339f89d9ec8a0","field":"drug.label_event","entity":"application:BLA761077"},{"fact_id":"79ffc8a7312aa9cb1eb771e6","field":"drug.marketing_status","entity":"application:BLA761077"},{"fact_id":"53f60a0886b1284cd5f480f2","field":"drug.biologic_status","entity":"application:BLA761077"},{"fact_id":"6565c2e2b5cb55125048825f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:NY"},{"fact_id":"e727f479f20b401ced33bd62","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:PA"},{"fact_id":"a259e62cb761a77719170452","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:OH"},{"fact_id":"d3bf4f2d681d3368e37f1ba3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:CA"},{"fact_id":"2ceffa575b6994a62efb4197","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:MI"},{"fact_id":"b5ed19c887c74ec75b38848e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:IL"},{"fact_id":"42b99f5519ef6eaf70ba78c6","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:NC"},{"fact_id":"f69c519942666b7213348bc2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:KY"},{"fact_id":"65f3368b33d6399729c1e2bb","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:CO"},{"fact_id":"4a1fdc40095424283a1d7d29","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513084301:IN"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:BLA761077","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"spending","reason":"no CMS Part D spending series for this brand name is in the edition"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}