{"answer":{"query":"Praluent","resolved_as":"applications","packages":10,"applications":["BLA125559"],"identity":{"application_numbers":["BLA125559"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2015-07-24","latest":"2020-12-01","packages_with_a_start_date":10}},"label_history":{"events_total":13,"non_cmc_events":12,"counts_by_class":{"EFFICACY":8,"LABELING":4},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA125559","submission_no":47,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-10-09","documents":[{"type":"Label","date":"2025-10-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125559s047lblcorrection.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125559Orig1s047Correctedltr.pdf","untrusted":true}}],"fact_id":"61afb4edfe5e52d3213728f3"},{"application":"BLA125559","submission_no":39,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-03-08","documents":[{"type":"Label","date":"2024-03-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125559s039lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-03-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125559Orig1s039ltr.pdf","untrusted":true}}],"fact_id":"70cbef763200c390b09edb05"},{"application":"BLA125559","submission_no":30,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-04-01","documents":[{"type":"Label","date":"2021-04-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-04-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125559Orig1s029,s030ltr.pdf","untrusted":true}}],"fact_id":"66fe0d1b51d2aa8b61598eb5"},{"application":"BLA125559","submission_no":29,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-04-01","documents":[{"type":"Label","date":"2021-04-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-04-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125559Orig1s029,s030ltr.pdf","untrusted":true}}],"fact_id":"7f95a5a2455ba8fc6e9e0c00"},{"application":"BLA125559","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-03-10","documents":[{"type":"Letter","date":"2020-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125559Orig1s024ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf","untrusted":true}}],"fact_id":"9e898ea94307ae42bafeb1dc"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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":"6759b689432a62b19a6fdd4c","field":"ndc.listing","entity":"ndc:00024590100"},{"fact_id":"e206f9b3d585e244831b4128","field":"ndc.listing","entity":"ndc:00024590101"},{"fact_id":"d4b747a7303256b0f69f4dd2","field":"ndc.listing","entity":"ndc:00024590200"},{"fact_id":"61afb4edfe5e52d3213728f3","field":"drug.label_event","entity":"application:BLA125559"},{"fact_id":"70cbef763200c390b09edb05","field":"drug.label_event","entity":"application:BLA125559"},{"fact_id":"66fe0d1b51d2aa8b61598eb5","field":"drug.label_event","entity":"application:BLA125559"},{"fact_id":"7f95a5a2455ba8fc6e9e0c00","field":"drug.label_event","entity":"application:BLA125559"},{"fact_id":"9e898ea94307ae42bafeb1dc","field":"drug.label_event","entity":"application:BLA125559"},{"fact_id":"c56881fea6401b74f847b246","field":"drug.marketing_status","entity":"application:BLA125559"},{"fact_id":"4f133307fe64d1481c45ff74","field":"drug.marketing_status","entity":"application:BLA125559"},{"fact_id":"b2713694a9b7f508b85812c3","field":"drug.biologic_status","entity":"application:BLA125559"},{"fact_id":"401e9ee67e4a114fd5e26ff5","field":"drug.orphan_designation","entity":"drug:alirocumab"},{"fact_id":"5fd0d3185a76938647f4f97a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61755002002:NC"},{"fact_id":"c66e613a542201035fe25734","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61755002002:CO"},{"fact_id":"a9fbfc700a204d0c1a44e6ba","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61755002102:TN"},{"fact_id":"154bbb625e3146e5296f4406","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61755002102:VT"},{"fact_id":"1acaf273f56c0d03ff035fa7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61755002102:DC"}],"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:BLA125559","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":"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."}