{"answer":{"query":"Nucala","resolved_as":"applications","packages":7,"applications":["BLA125526","BLA761122"],"identity":{"application_numbers":["BLA125526","BLA761122"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, POWDER, FOR SOLUTION","untrusted":true},{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2015-11-04","latest":"2022-01-22","packages_with_a_start_date":7}},"label_history":{"events_total":16,"non_cmc_events":15,"counts_by_class":{"LABELING":8,"EFFICACY":7},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA761122","submission_no":22,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-06","documents":[{"type":"Letter","date":"2025-08-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761122Orig1s022ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-08-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761122s022lbl.pdf","untrusted":true}}],"fact_id":"53119e51e64c95fb8fa0b6d3"},{"application":"BLA125526","submission_no":7,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-05-22","documents":[{"type":"Letter","date":"2025-05-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125526Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125526s007lbl.pdf","untrusted":true}}],"fact_id":"74eb2d2af2234455d1eea2db"},{"application":"BLA125526","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-08","documents":[{"type":"Label","date":"2023-03-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-03-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125526Orig1s021;761122Orig1s011Corrected_ltr.pdf","untrusted":true}}],"fact_id":"a0067d8ec17aac37c7b0643d"},{"application":"BLA761122","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-08","documents":[{"type":"Label","date":"2023-03-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-03-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125526Orig1s021;761122Orig1s011Corrected_ltr.pdf","untrusted":true}}],"fact_id":"ff6638bd94b0e328a5370699"},{"application":"BLA125526","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-01-22","documents":[{"type":"Letter","date":"2022-01-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125526Orig1s019; 761122Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-01-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf","untrusted":true}}],"fact_id":"9c2380595fb566de75b534bf"}],"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; 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":"BLA125526","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"NUCALA","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER","untrusted":true},"strength":{"text":"100MG","untrusted":true}},{"application":"BLA761122","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"NUCALA","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"100MG/ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":7,"most_recent":[{"recall_number":"D-1876-2019","classification":"Class II","status":"Terminated","report_date":"2019-10-02","recall_initiated":"2019-09-06","recalling_firm":{"text":"Cardinal Health dba Specialty Pharmaceutical Services","untrusted":true},"reason":{"text":"Temperature Abuse; Product stored and shipped outside of labeled storage requirements.","untrusted":true},"packages_named":1,"fact_id":"2b7705b00863f19de47d79c7"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Mepolizumab","untrusted":true},"brand":{"text":"Nucala","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":86623798.59,"claims":24392,"beneficiaries":3634,"average_spending_per_claim_usd":3551.3200471,"fact_id":"f37df48326410f7153831c1e"},{"year":2021,"gross_spending_usd":132108366.77,"claims":34815,"beneficiaries":4755,"average_spending_per_claim_usd":3794.5818403,"fact_id":"2d36e53c7fcc182cee560ce6"},{"year":2022,"gross_spending_usd":193350670.97,"claims":47988,"beneficiaries":6361,"average_spending_per_claim_usd":4029.1462651,"fact_id":"d76c4f5fe28c28c1e8254988"},{"year":2023,"gross_spending_usd":260986344.47,"claims":59055,"beneficiaries":7618,"average_spending_per_claim_usd":4419.3776051,"fact_id":"003527046f5c0ce9ae3982ff"},{"year":2024,"gross_spending_usd":317907428.14,"claims":72258,"beneficiaries":9062,"average_spending_per_claim_usd":4399.615657,"fact_id":"7689c39d369f99de543388ee"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"biologic_status":{"products":[{"application":"BLA125526","status":"Reference","name":{"text":"Nucala","untrusted":true},"proper_name":{"text":"mepolizumab","untrusted":true},"license_status":"Licensed","approval_date":"2015-11-04","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":"942c4a94d5d8b9149ecbc9a4"},{"application":"BLA761122","status":"Reference","name":{"text":"Nucala","untrusted":true},"proper_name":{"text":"mepolizumab","untrusted":true},"license_status":"Licensed","approval_date":"2019-06-06","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":"b61a3517d35d63beb0371164"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"payment_limit":{"codes":[{"hcpcs":"J2182","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":32.181,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":1,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"8b773ef428c2fb17c24bbd99"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"mepolizumab","untrusted":true},"designation_count":3,"approved_count":3,"recent":[{"designated":"2011-07-14","use":{"text":"Treatment of Churg-Strauss Syndrome","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"GlaxoSmithKline LLC","untrusted":true},"approved":true},{"designated":"2011-07-14","use":{"text":"Treatment of Churg-Strauss Syndrome","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"GlaxoSmithKline LLC","untrusted":true},"approved":true},{"designated":"2004-05-28","use":{"text":"Treatment of hypereosinophilic syndrome","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"GlaxoSmithKline LLC","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"8cd13a31f486fe482f6d6c08"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":12,"all_states_medicaid_reimbursed_usd":3725071.4,"all_states_medicaid_paid_prescriptions":1025,"top_states":[{"state":"OK","medicaid_paid_prescriptions":229,"medicaid_reimbursed_usd":796123.4,"total_reimbursed_usd":818446.08,"packages":2,"covers":"fee_for_service_only","fact_id":"cd330018fa2581a700ddadac"},{"state":"OH","medicaid_paid_prescriptions":119,"medicaid_reimbursed_usd":653672.8,"total_reimbursed_usd":653672.8,"packages":1,"covers":"fee_for_service_only","fact_id":"bffbe4327ca3ae9692760edf"},{"state":"UT","medicaid_paid_prescriptions":66,"medicaid_reimbursed_usd":377539.2,"total_reimbursed_usd":377539.2,"packages":1,"covers":"fee_for_service_only","fact_id":"cd830db53991d8720664b022"},{"state":"PA","medicaid_paid_prescriptions":73,"medicaid_reimbursed_usd":368877.72,"total_reimbursed_usd":375691.59,"packages":1,"covers":"all_record_types","fact_id":"8b4733f11d94c26da49f206e"},{"state":"VT","medicaid_paid_prescriptions":91,"medicaid_reimbursed_usd":345982.59,"total_reimbursed_usd":345982.59,"packages":1,"covers":"all_record_types","fact_id":"602d4ef90713844ef7ecc234"},{"state":"MD","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":257235.68,"total_reimbursed_usd":257292.68,"packages":1,"covers":"all_record_types","fact_id":"b3aaa27a5e67618535bb0967"},{"state":"MS","medicaid_paid_prescriptions":63,"medicaid_reimbursed_usd":229898.09,"total_reimbursed_usd":233602.59,"packages":1,"covers":"fee_for_service_only","fact_id":"9718eca20902a38d76cd5987"},{"state":"MO","medicaid_paid_prescriptions":64,"medicaid_reimbursed_usd":205458.7,"total_reimbursed_usd":326873.48,"packages":1,"covers":"all_record_types","fact_id":"f8965556ebb55c87f26df487"},{"state":"AL","medicaid_paid_prescriptions":52,"medicaid_reimbursed_usd":205442.18,"total_reimbursed_usd":209210.9,"packages":1,"covers":"all_record_types","fact_id":"64e82597b383fdb46942d9a1"},{"state":"TX","medicaid_paid_prescriptions":94,"medicaid_reimbursed_usd":124194.42,"total_reimbursed_usd":143522.71,"packages":1,"covers":"all_record_types","fact_id":"b04f3f30c9176b5ba7a0940d"}],"unlabelled_state_code_xx":null,"built_from_facts":13,"facts_fee_for_service_only":5,"older_year_facts_not_used":109,"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":"c5d7b7146484b3db2ac11630","field":"ndc.listing","entity":"ndc:00173088101"},{"fact_id":"80a3cd8bf5f8f6fbcf3199de","field":"ndc.listing","entity":"ndc:00173088161"},{"fact_id":"bc033f39fa8b05551c587336","field":"ndc.listing","entity":"ndc:00173089201"},{"fact_id":"53119e51e64c95fb8fa0b6d3","field":"drug.label_event","entity":"application:BLA761122"},{"fact_id":"74eb2d2af2234455d1eea2db","field":"drug.label_event","entity":"application:BLA125526"},{"fact_id":"a0067d8ec17aac37c7b0643d","field":"drug.label_event","entity":"application:BLA125526"},{"fact_id":"ff6638bd94b0e328a5370699","field":"drug.label_event","entity":"application:BLA761122"},{"fact_id":"9c2380595fb566de75b534bf","field":"drug.label_event","entity":"application:BLA125526"},{"fact_id":"f715e0bb6d4f0741f8d8db95","field":"drug.marketing_status","entity":"application:BLA125526"},{"fact_id":"5f753c04253537f36d6c05f9","field":"drug.marketing_status","entity":"application:BLA761122"},{"fact_id":"2b7705b00863f19de47d79c7","field":"ndc.recall","entity":"ndc:00173089242"},{"fact_id":"f37df48326410f7153831c1e","field":"drug.partd_spending","entity":"drug:mepolizumab|nucala"},{"fact_id":"2d36e53c7fcc182cee560ce6","field":"drug.partd_spending","entity":"drug:mepolizumab|nucala"},{"fact_id":"d76c4f5fe28c28c1e8254988","field":"drug.partd_spending","entity":"drug:mepolizumab|nucala"},{"fact_id":"003527046f5c0ce9ae3982ff","field":"drug.partd_spending","entity":"drug:mepolizumab|nucala"},{"fact_id":"7689c39d369f99de543388ee","field":"drug.partd_spending","entity":"drug:mepolizumab|nucala"},{"fact_id":"942c4a94d5d8b9149ecbc9a4","field":"drug.biologic_status","entity":"application:BLA125526"},{"fact_id":"b61a3517d35d63beb0371164","field":"drug.biologic_status","entity":"application:BLA761122"},{"fact_id":"8b773ef428c2fb17c24bbd99","field":"drug.asp_price","entity":"hcpcs:J2182"},{"fact_id":"8cd13a31f486fe482f6d6c08","field":"drug.orphan_designation","entity":"drug:mepolizumab"},{"fact_id":"cd330018fa2581a700ddadac","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173089201:OK"},{"fact_id":"bffbe4327ca3ae9692760edf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173089242:OH"},{"fact_id":"cd830db53991d8720664b022","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173089201:UT"},{"fact_id":"8b4733f11d94c26da49f206e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173089242:PA"},{"fact_id":"602d4ef90713844ef7ecc234","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173089201:VT"},{"fact_id":"b3aaa27a5e67618535bb0967","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173088101:MD"},{"fact_id":"9718eca20902a38d76cd5987","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173089201:MS"},{"fact_id":"f8965556ebb55c87f26df487","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173088101:MO"},{"fact_id":"64e82597b383fdb46942d9a1","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173089242:AL"},{"fact_id":"b04f3f30c9176b5ba7a0940d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173090442:TX"}],"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:BLA125526","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:BLA761122","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":"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":"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."}