{"answer":{"query":"Vyvgart Hytrulo","resolved_as":"applications","packages":3,"applications":["BLA761304"],"identity":{"application_numbers":["BLA761304"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2023-06-20","latest":"2025-04-10","packages_with_a_start_date":3}},"label_history":{"events_total":8,"non_cmc_events":8,"counts_by_class":{"EFFICACY":5,"LABELING":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761304","submission_no":18,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-05-08","documents":[{"type":"Letter","date":"2026-05-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761195Orig1s016; 761304Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-05-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761304s018lbl.pdf","untrusted":true}}],"fact_id":"db5b8d3740d807d9f4dd6983"},{"application":"BLA761304","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-26","documents":[{"type":"Letter","date":"2026-03-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761304Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761304s019lbl.pdf","untrusted":true}}],"fact_id":"0f17030fcc435a326de6a018"},{"application":"BLA761304","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-10-17","documents":[{"type":"Label","date":"2025-10-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761304s010lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761195Orig1s012,761304Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"8350e5873206db0d8a5b4d7c"},{"application":"BLA761304","submission_no":8,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-04-10","documents":[{"type":"Label","date":"2025-04-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761304Orig1s008lbl","untrusted":true}},{"type":"Letter","date":"2025-04-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761304Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"a015b0565a829903f0ba05fe"},{"application":"BLA761304","submission_no":3,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-08-08","documents":[{"type":"Letter","date":"2024-08-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761195Orig1s004;761304Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761195s004,761304s003lbl.pdf","untrusted":true}}],"fact_id":"3af8b853ca0670d7f3ff7871"}],"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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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":"f080e32b581c5eb949883fe0","field":"ndc.listing","entity":"ndc:73475122101"},{"fact_id":"65bf5ee2162eade2f768323e","field":"ndc.listing","entity":"ndc:73475122104"},{"fact_id":"dc85832b79ee24a60c6e308e","field":"ndc.listing","entity":"ndc:73475310203"},{"fact_id":"db5b8d3740d807d9f4dd6983","field":"drug.label_event","entity":"application:BLA761304"},{"fact_id":"0f17030fcc435a326de6a018","field":"drug.label_event","entity":"application:BLA761304"},{"fact_id":"8350e5873206db0d8a5b4d7c","field":"drug.label_event","entity":"application:BLA761304"},{"fact_id":"a015b0565a829903f0ba05fe","field":"drug.label_event","entity":"application:BLA761304"},{"fact_id":"3af8b853ca0670d7f3ff7871","field":"drug.label_event","entity":"application:BLA761304"},{"fact_id":"42cd9706d464f7da83ca5c71","field":"drug.marketing_status","entity":"application:BLA761304"},{"fact_id":"8c175e6ac87d942c95a6c13f","field":"drug.partd_spending","entity":"drug:efgartigimod-hyaluronidas-qvfc|vyvgart-hytrulo"},{"fact_id":"038d9121b6425c5218602d74","field":"drug.partd_spending","entity":"drug:efgartigimod-hyaluronidas-qvfc|vyvgart-hytrulo"},{"fact_id":"9f1be6dac8ae1b7fdf7d75d7","field":"drug.biologic_status","entity":"application:BLA761304"},{"fact_id":"31cb9d5ab6d2fd9d14abffb6","field":"drug.asp_price","entity":"hcpcs:J9334"},{"fact_id":"fb4e1d05c48f1026c7c66970","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:CA"},{"fact_id":"53359b5ed58fd83e7324206d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:NC"},{"fact_id":"15fdbf0b150c030408a133cf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:NY"},{"fact_id":"3861bf9dc986c2695987303d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:NJ"},{"fact_id":"1b962820061e0c4e5035688e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:IN"},{"fact_id":"442426df66de91e1e0cd0d3e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:VA"},{"fact_id":"c87131feee954f02be652d93","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:FL"},{"fact_id":"6e784218e705ceee2c0777b7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:OH"},{"fact_id":"fa8f11467ce55fde0d6f4167","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:PA"},{"fact_id":"aa018d74ea3e4280df33f51e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73475310203:MI"}],"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:BLA761304","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":"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."}