{"answer":{"query":"Darzalex Faspro","resolved_as":"applications","packages":1,"applications":["BLA761145"],"identity":{"application_numbers":["BLA761145"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2020-05-01","latest":"2020-05-01","packages_with_a_start_date":1}},"label_history":{"events_total":14,"non_cmc_events":14,"counts_by_class":{"LABELING":6,"EFFICACY":8},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761145","submission_no":39,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-12","documents":[{"type":"Letter","date":"2026-02-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761145Orig1s039ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s039lbl.pdf","untrusted":true}}],"fact_id":"38add821fd72060f3d64cbf6"},{"application":"BLA761145","submission_no":28,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-01-27","documents":[{"type":"Letter","date":"2026-01-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761145Orig1s028ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-01-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s028lbl.pdf","untrusted":true}}],"fact_id":"0338af4d40e5632a1586c7ef"},{"application":"BLA761145","submission_no":32,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-11-19","documents":[{"type":"Label","date":"2025-11-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s032lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-11-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s032ltr.pdf","untrusted":true}}],"fact_id":"48ce2692655f860895ecc3c6"},{"application":"BLA761145","submission_no":35,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-11-14","documents":[{"type":"Label","date":"2025-11-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s035lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-11-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s035ltr.pdf","untrusted":true}}],"fact_id":"2305d8daa51faf697bc67d4d"},{"application":"BLA761145","submission_no":29,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-11-06","documents":[{"type":"Letter","date":"2025-11-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-11-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s029lbl.pdf","untrusted":true}}],"fact_id":"bb8f9a4d90709e4b8a2cd0dc"}],"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":"BLA761145","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"DARZALEX FASPRO","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"120MG;2000UNITS/ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Daratumumab-Hyaluronidase-Fihj","untrusted":true},"brand":{"text":"Darzalex Faspro","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":5152437.03,"claims":308,"beneficiaries":83,"average_spending_per_claim_usd":16728.691656,"fact_id":"7041b7466d27d76938f39f51"},{"year":2021,"gross_spending_usd":17798800.86,"claims":1160,"beneficiaries":201,"average_spending_per_claim_usd":15343.793845,"fact_id":"c754f0f638ae710dfd4cca91"},{"year":2022,"gross_spending_usd":41953678.12,"claims":2601,"beneficiaries":473,"average_spending_per_claim_usd":16129.826267,"fact_id":"2493cadcb7324f812a43edf1"},{"year":2023,"gross_spending_usd":69656583.96,"claims":4452,"beneficiaries":695,"average_spending_per_claim_usd":15646.132965,"fact_id":"554e74005f5be582edc0b065"},{"year":2024,"gross_spending_usd":102716642.36,"claims":7367,"beneficiaries":1125,"average_spending_per_claim_usd":13942.804718,"fact_id":"40ca58e4e0e338104c4fe076"}],"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":"BLA761145","status":"Reference","name":{"text":"Darzalex Faspro","untrusted":true},"proper_name":{"text":"daratumumab and hyaluronidase-fihj","untrusted":true},"license_status":"Licensed","approval_date":"2020-05-01","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":"c2640d0ffffe8c1f9360d174"}],"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":"J9144","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":57.973,"dosage_descriptor":{"text":"10 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":"721c8bc5f5da987be95d1bfe"}],"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":"daratumumab","untrusted":true},"designation_count":11,"approved_count":7,"recent":[{"designated":"2017-09-05","use":{"text":"Treatment of systemic amyloid light-chain (AL) amyloidosis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Janssen Research & Development, LLC","untrusted":true},"approved":false},{"designated":"2015-11-09","use":{"text":"Treatment of diffuse large B-cell lymphoma.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Janssen Research & Development, LLC","untrusted":true},"approved":false},{"designated":"2015-08-20","use":{"text":"Treatment of mantle cell lymphoma.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Janssen Research & Development, LLC","untrusted":true},"approved":false},{"designated":"2015-08-06","use":{"text":"Treatment of follicular lymphoma","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Janssen Research & Development, LLC","untrusted":true},"approved":false},{"designated":"2013-05-06","use":{"text":"Treatment of multiple myeloma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Janssen Biotech, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"b01471cd82ca986faed129ec"}],"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":5,"all_states_medicaid_reimbursed_usd":9834406,"all_states_medicaid_paid_prescriptions":788,"top_states":[{"state":"PR","medicaid_paid_prescriptions":283,"medicaid_reimbursed_usd":5230787,"total_reimbursed_usd":5230787,"packages":1,"covers":"all_record_types","fact_id":"1a62ed6c735122d8ad59e6db"},{"state":"SD","medicaid_paid_prescriptions":110,"medicaid_reimbursed_usd":2321441.59,"total_reimbursed_usd":2321441.59,"packages":1,"covers":"all_record_types","fact_id":"d6833086ae90097c80a6c9bc"},{"state":"KY","medicaid_paid_prescriptions":211,"medicaid_reimbursed_usd":1478938.56,"total_reimbursed_usd":1478938.56,"packages":1,"covers":"fee_for_service_only","fact_id":"39a720322bc2b85a3a053e20"},{"state":"NH","medicaid_paid_prescriptions":76,"medicaid_reimbursed_usd":592954.66,"total_reimbursed_usd":592954.66,"packages":1,"covers":"fee_for_service_only","fact_id":"d5538a17a525c8c40491cd4d"},{"state":"MS","medicaid_paid_prescriptions":108,"medicaid_reimbursed_usd":210284.19,"total_reimbursed_usd":248678.6,"packages":1,"covers":"fee_for_service_only","fact_id":"8fdd5b35262861b7e3196ab3"}],"unlabelled_state_code_xx":null,"built_from_facts":5,"facts_fee_for_service_only":3,"older_year_facts_not_used":41,"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":"749d36c88c3d6172bb9bc5f4","field":"ndc.listing","entity":"ndc:57894050301"},{"fact_id":"38add821fd72060f3d64cbf6","field":"drug.label_event","entity":"application:BLA761145"},{"fact_id":"0338af4d40e5632a1586c7ef","field":"drug.label_event","entity":"application:BLA761145"},{"fact_id":"48ce2692655f860895ecc3c6","field":"drug.label_event","entity":"application:BLA761145"},{"fact_id":"2305d8daa51faf697bc67d4d","field":"drug.label_event","entity":"application:BLA761145"},{"fact_id":"bb8f9a4d90709e4b8a2cd0dc","field":"drug.label_event","entity":"application:BLA761145"},{"fact_id":"41b26ac9bd0ce921a2393583","field":"drug.marketing_status","entity":"application:BLA761145"},{"fact_id":"7041b7466d27d76938f39f51","field":"drug.partd_spending","entity":"drug:daratumumab-hyaluronidase-fihj|darzalex-faspro"},{"fact_id":"c754f0f638ae710dfd4cca91","field":"drug.partd_spending","entity":"drug:daratumumab-hyaluronidase-fihj|darzalex-faspro"},{"fact_id":"2493cadcb7324f812a43edf1","field":"drug.partd_spending","entity":"drug:daratumumab-hyaluronidase-fihj|darzalex-faspro"},{"fact_id":"554e74005f5be582edc0b065","field":"drug.partd_spending","entity":"drug:daratumumab-hyaluronidase-fihj|darzalex-faspro"},{"fact_id":"40ca58e4e0e338104c4fe076","field":"drug.partd_spending","entity":"drug:daratumumab-hyaluronidase-fihj|darzalex-faspro"},{"fact_id":"c2640d0ffffe8c1f9360d174","field":"drug.biologic_status","entity":"application:BLA761145"},{"fact_id":"721c8bc5f5da987be95d1bfe","field":"drug.asp_price","entity":"hcpcs:J9144"},{"fact_id":"b01471cd82ca986faed129ec","field":"drug.orphan_designation","entity":"drug:daratumumab"},{"fact_id":"1a62ed6c735122d8ad59e6db","field":"ndc.medicaid_state_utilization","entity":"ndc_state:57894050301:PR"},{"fact_id":"d6833086ae90097c80a6c9bc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:57894050301:SD"},{"fact_id":"39a720322bc2b85a3a053e20","field":"ndc.medicaid_state_utilization","entity":"ndc_state:57894050301:KY"},{"fact_id":"d5538a17a525c8c40491cd4d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:57894050301:NH"},{"fact_id":"8fdd5b35262861b7e3196ab3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:57894050301:MS"}],"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:BLA761145","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":"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."}