{"answer":{"query":"Taltz","resolved_as":"applications","packages":8,"applications":["BLA125521"],"identity":{"application_numbers":["BLA125521"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2016-03-22","latest":"2024-02-02","packages_with_a_start_date":8}},"label_history":{"events_total":14,"non_cmc_events":13,"counts_by_class":{"LABELING":6,"EFFICACY":6,"UNKNOWN":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA125521","submission_no":32,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-20","documents":[{"type":"Letter","date":"2024-08-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125521Orig1s032ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125521s032lbl.pdf","untrusted":true}}],"fact_id":"911ad38078e2ef29a6132cc1"},{"application":"BLA125521","submission_no":28,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-09-13","documents":[{"type":"Letter","date":"2023-09-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125521Orig1s028ltr.pdf","untrusted":true}}],"fact_id":"a5adb6ae03af93fe0557b6b8"},{"application":"BLA125521","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-07-27","documents":[{"type":"Letter","date":"2022-07-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125521Orig1s024ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-07-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf","untrusted":true}}],"fact_id":"2957cf95117005afb0fdfec2"},{"application":"BLA125521","submission_no":23,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-05-04","documents":[],"fact_id":"e7d1fb03098daf9752445f5f"},{"application":"BLA125521","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-10","documents":[{"type":"Label","date":"2021-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125521s014lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125521Orig1s014ltr.pdf","untrusted":true}}],"fact_id":"a5c13d1b7dcfbee263553830"}],"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; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"BLA125521","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TALTZ","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"80MG/ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":8,"most_recent":[{"recall_number":"D-0741-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"44f5e8d0468b958fb046c584"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Lilly Cares Foundation","untrusted":true},"type":"manufacturer","url":"https://www.lillycares.com/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"biologic_status":{"products":[{"application":"BLA125521","status":"Reference","name":{"text":"Taltz","untrusted":true},"proper_name":{"text":"ixekizumab","untrusted":true},"license_status":"Licensed","approval_date":"2016-03-22","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":0,"biosimilars":[],"interchangeables":[],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"e0910cdf401805ae4808e815"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"medicaid_state_utilization":{"year":2025,"states_with_data":10,"all_states_medicaid_reimbursed_usd":7170821.41,"all_states_medicaid_paid_prescriptions":871,"top_states":[{"state":"MS","medicaid_paid_prescriptions":80,"medicaid_reimbursed_usd":1124765.46,"total_reimbursed_usd":1124765.46,"packages":1,"covers":"fee_for_service_only","fact_id":"ee405c263a77f33301b23b65"},{"state":"IN","medicaid_paid_prescriptions":121,"medicaid_reimbursed_usd":854825.56,"total_reimbursed_usd":854825.56,"packages":1,"covers":"fee_for_service_only","fact_id":"13dcb8c0c500ab3d73ad45d8"},{"state":"PA","medicaid_paid_prescriptions":132,"medicaid_reimbursed_usd":848142.07,"total_reimbursed_usd":947731.24,"packages":1,"covers":"all_record_types","fact_id":"18274b05fbb241b38d86c247"},{"state":"CA","medicaid_paid_prescriptions":108,"medicaid_reimbursed_usd":806109.2,"total_reimbursed_usd":813138.95,"packages":1,"covers":"all_record_types","fact_id":"f3923d59f35be5e33a67e099"},{"state":"TN","medicaid_paid_prescriptions":107,"medicaid_reimbursed_usd":754008.48,"total_reimbursed_usd":754011.48,"packages":1,"covers":"all_record_types","fact_id":"a8ef3f848b6e614dfe6129e9"},{"state":"MN","medicaid_paid_prescriptions":51,"medicaid_reimbursed_usd":733354.23,"total_reimbursed_usd":733354.23,"packages":1,"covers":"fee_for_service_only","fact_id":"d9bc011650f378c1600e7201"},{"state":"DC","medicaid_paid_prescriptions":84,"medicaid_reimbursed_usd":664429.7,"total_reimbursed_usd":664429.7,"packages":1,"covers":"all_record_types","fact_id":"9d74ed9bb92f15ccec2de0f5"},{"state":"UT","medicaid_paid_prescriptions":59,"medicaid_reimbursed_usd":508376.88,"total_reimbursed_usd":508376.88,"packages":1,"covers":"fee_for_service_only","fact_id":"1f5771de042cf7acf42085e8"},{"state":"OH","medicaid_paid_prescriptions":77,"medicaid_reimbursed_usd":493617.16,"total_reimbursed_usd":493617.16,"packages":1,"covers":"all_record_types","fact_id":"aabb9c9ff7068dc2240d2b1d"},{"state":"MI","medicaid_paid_prescriptions":52,"medicaid_reimbursed_usd":383192.67,"total_reimbursed_usd":383192.67,"packages":1,"covers":"all_record_types","fact_id":"afeae3aa55b72b22e4b4e9bf"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":1254,"medicaid_reimbursed_usd":8697602.97,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":12,"facts_fee_for_service_only":5,"older_year_facts_not_used":107,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). 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":"089b6a959c05fd87ef64aa3f","field":"ndc.listing","entity":"ndc:00002144509"},{"fact_id":"46e9ca7e909f669b39b62452","field":"ndc.listing","entity":"ndc:00002144511"},{"fact_id":"c047ee3218f43b10934bc58e","field":"ndc.listing","entity":"ndc:00002144527"},{"fact_id":"911ad38078e2ef29a6132cc1","field":"drug.label_event","entity":"application:BLA125521"},{"fact_id":"a5adb6ae03af93fe0557b6b8","field":"drug.label_event","entity":"application:BLA125521"},{"fact_id":"2957cf95117005afb0fdfec2","field":"drug.label_event","entity":"application:BLA125521"},{"fact_id":"e7d1fb03098daf9752445f5f","field":"drug.label_event","entity":"application:BLA125521"},{"fact_id":"a5c13d1b7dcfbee263553830","field":"drug.label_event","entity":"application:BLA125521"},{"fact_id":"774202d9bb23646d7c2a3d88","field":"drug.marketing_status","entity":"application:BLA125521"},{"fact_id":"44f5e8d0468b958fb046c584","field":"ndc.recall","entity":"ndc:00002144511"},{"fact_id":"e0910cdf401805ae4808e815","field":"drug.biologic_status","entity":"application:BLA125521"},{"fact_id":"ee405c263a77f33301b23b65","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002144527:MS"},{"fact_id":"13dcb8c0c500ab3d73ad45d8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002890511:IN"},{"fact_id":"18274b05fbb241b38d86c247","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002890511:PA"},{"fact_id":"f3923d59f35be5e33a67e099","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002890511:CA"},{"fact_id":"a8ef3f848b6e614dfe6129e9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002890511:TN"},{"fact_id":"d9bc011650f378c1600e7201","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002144527:MN"},{"fact_id":"9d74ed9bb92f15ccec2de0f5","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002144511:DC"},{"fact_id":"1f5771de042cf7acf42085e8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002772411:UT"},{"fact_id":"aabb9c9ff7068dc2240d2b1d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002890511:OH"},{"fact_id":"afeae3aa55b72b22e4b4e9bf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002772411: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:BLA125521","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":"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":"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."}