{"answer":{"query":"Fasenra","resolved_as":"applications","packages":6,"applications":["BLA761070"],"identity":{"application_numbers":["BLA761070"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2017-11-14","latest":"2024-06-03","packages_with_a_start_date":6}},"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"EFFICACY":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761070","submission_no":23,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-05-13","documents":[{"type":"Letter","date":"2026-06-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761070Orig1s023correctedltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761070s023lbl.pdf","untrusted":true}}],"fact_id":"ff9d97bd80f576d85836451f"},{"application":"BLA761070","submission_no":21,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-09-17","documents":[{"type":"Label","date":"2024-09-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-09-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761070Orig1s0021ltr.pdf","untrusted":true}}],"fact_id":"b0755245aaade4fac9101caf"},{"application":"BLA761070","submission_no":20,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-04-05","documents":[{"type":"Label","date":"2024-04-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070Orig1s020correctedlbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-04-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761070Orig1s020correctedltr.pdf","untrusted":true}}],"fact_id":"29e83ca2fe0c97b04b018db0"},{"application":"BLA761070","submission_no":5,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-10-03","documents":[{"type":"Label","date":"2019-10-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761070s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-10-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761070Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"06091a9239f903ce52c76bca"}],"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; 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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":"Benralizumab; benralizumab","untrusted":true},"designation_count":5,"approved_count":2,"recent":[{"designated":"2021-11-01","use":{"text":"Treatment of Eosinophilic Gastritis (EG)","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"AstraZeneca Pharmaceuticals LP","untrusted":true},"approved":false},{"designated":"2021-11-01","use":{"text":"Treatment of eosinophilic gastroenteritis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"AstraZeneca Pharmaceuticals LP","untrusted":true},"approved":false},{"designated":"2019-08-26","use":{"text":"Treatment of eosinophilic esophagitis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"AstraZeneca Pharmaceuticals LP","untrusted":true},"approved":false},{"designated":"2019-02-01","use":{"text":"Treatment of hypereosinophilic syndrome","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"AstraZeneca Pharmaceuticals LP","untrusted":true},"approved":true},{"designated":"2018-11-21","use":{"text":"Treatment of eosinophilic granulomatosis with polyangiitis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"AstraZeneca Pharmaceuticals LP","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"793965be5abb0abe63133646"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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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:BLA761070","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."}