{"answer":{"query":"Benlysta","resolved_as":"applications","packages":7,"applications":["BLA125370","BLA761043"],"identity":{"application_numbers":["BLA125370","BLA761043"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION","untrusted":true},{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2011-03-10","latest":"2020-06-02","packages_with_a_start_date":7}},"label_history":{"events_total":30,"non_cmc_events":30,"counts_by_class":{"LABELING":21,"EFFICACY":9},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA125370","submission_no":89,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-10-30","documents":[{"type":"Label","date":"2026-11-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125370s089lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-11-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125370Orig1s089; 761043Orig1s038ltr.pdf","untrusted":true}}],"fact_id":"63d84bd033c27d872ce5eb69"},{"application":"BLA761043","submission_no":38,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-10-30","documents":[{"type":"Label","date":"2026-11-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761043s038lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-11-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125370Orig1s089; 761043Orig1s038ltr.pdf","untrusted":true}}],"fact_id":"c5014421e31fcddaa04989c0"},{"application":"BLA125370","submission_no":90,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-21","documents":[{"type":"Letter","date":"2026-08-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761043Orig1s039;125370Orig1s090ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125370s090lbl.pdf","untrusted":true}}],"fact_id":"81b22913f85326049603d365"},{"application":"BLA761043","submission_no":39,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-21","documents":[{"type":"Letter","date":"2026-08-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761043Orig1s039;125370Orig1s090ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761043s039lbl.pdf","untrusted":true}}],"fact_id":"3364ae3d8cbe450755049773"},{"application":"BLA125370","submission_no":85,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-20","documents":[{"type":"Label","date":"2025-06-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125370s085lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125370Orig1s085ltr.pdf","untrusted":true}}],"fact_id":"73a201185eb13efc31be702a"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"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":"BLA125370","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BENLYSTA","untrusted":true},"form":{"text":"INJECTABLE; INJECTION","untrusted":true},"strength":{"text":"400MG","untrusted":true}},{"application":"BLA125370","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BENLYSTA","untrusted":true},"form":{"text":"INJECTABLE; INJECTION","untrusted":true},"strength":{"text":"120MG","untrusted":true}},{"application":"BLA761043","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BENLYSTA","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"200MG/ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":7,"most_recent":[{"recall_number":"D-0540-2025","classification":"Class II","status":"Ongoing","report_date":"2025-07-30","recall_initiated":"2025-04-21","recalling_firm":{"text":"Mckesson Medical-Surgical Inc. 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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:BLA125370","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:BLA761043","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."}