{"answer":{"query":"Emgality","resolved_as":"applications","packages":4,"applications":["BLA761063"],"identity":{"application_numbers":["BLA761063"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2018-09-27","latest":"2019-06-17","packages_with_a_start_date":4}},"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":4,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761063","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-05","documents":[{"type":"Letter","date":"2026-06-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761063Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761063s013lbl.pdf","untrusted":true}}],"fact_id":"0b8c9fdce246ee0d4987b286"},{"application":"BLA761063","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-21","documents":[{"type":"Label","date":"2025-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761063s010lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761063Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"b215ac4de9815ac4947e63c6"},{"application":"BLA761063","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-05-24","documents":[{"type":"Letter","date":"2022-05-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761063Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-05-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761063s006lbl.pdf","untrusted":true}}],"fact_id":"058e06e506c065ed2a154910"},{"application":"BLA761063","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-12-05","documents":[{"type":"Letter","date":"2019-12-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761063Orig1s004ltr.pdf","untrusted":true}},{"type":"Label","date":"2019-12-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s004lbl.pdf","untrusted":true}}],"fact_id":"7496a4d106ce46bccf4655ca"},{"application":"BLA761063","submission_no":3,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-06-04","documents":[{"type":"Label","date":"2019-06-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-06-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761063Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"ba8510f42f273372efc7d7e6"}],"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":"BLA761063","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"EMGALITY","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"120MG/ML","untrusted":true}}]},"biologic_status":{"products":[{"application":"BLA761063","status":"Reference","name":{"text":"Emgality","untrusted":true},"proper_name":{"text":"galcanezumab-gnlm","untrusted":true},"license_status":"Licensed","approval_date":"2018-09-27","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":"41c7606f19f7ef1e7ea24b5b"}],"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":3,"all_states_medicaid_reimbursed_usd":712103.29,"all_states_medicaid_paid_prescriptions":859,"top_states":[{"state":"OH","medicaid_paid_prescriptions":736,"medicaid_reimbursed_usd":558820.42,"total_reimbursed_usd":574834.22,"packages":1,"covers":"fee_for_service_only","fact_id":"a2baa1fa13cd0f04c8530f14"},{"state":"ID","medicaid_paid_prescriptions":61,"medicaid_reimbursed_usd":109681.84,"total_reimbursed_usd":109681.84,"packages":1,"covers":"all_record_types","fact_id":"21836ea702803976587770b5"},{"state":"WV","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":43601.03,"total_reimbursed_usd":48278.97,"packages":1,"covers":"all_record_types","fact_id":"fcd32a7f16d70dc1fb1f20b7"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":1,"older_year_facts_not_used":120,"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":"f8ec9f5dda6f985cf3592dd0","field":"ndc.listing","entity":"ndc:00002143611"},{"fact_id":"f933b47f97dbb9f796e57f06","field":"ndc.listing","entity":"ndc:00002143661"},{"fact_id":"2455b5c373eeea5317a225ba","field":"ndc.listing","entity":"ndc:00002237711"},{"fact_id":"0b8c9fdce246ee0d4987b286","field":"drug.label_event","entity":"application:BLA761063"},{"fact_id":"b215ac4de9815ac4947e63c6","field":"drug.label_event","entity":"application:BLA761063"},{"fact_id":"058e06e506c065ed2a154910","field":"drug.label_event","entity":"application:BLA761063"},{"fact_id":"7496a4d106ce46bccf4655ca","field":"drug.label_event","entity":"application:BLA761063"},{"fact_id":"ba8510f42f273372efc7d7e6","field":"drug.label_event","entity":"application:BLA761063"},{"fact_id":"456370f0f32ca5a04de630e9","field":"drug.marketing_status","entity":"application:BLA761063"},{"fact_id":"41c7606f19f7ef1e7ea24b5b","field":"drug.biologic_status","entity":"application:BLA761063"},{"fact_id":"a2baa1fa13cd0f04c8530f14","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002237711:OH"},{"fact_id":"21836ea702803976587770b5","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002311509:ID"},{"fact_id":"fcd32a7f16d70dc1fb1f20b7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002237711:WV"}],"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:BLA761063","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":"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."}