{"answer":{"query":"Krystexxa","resolved_as":"applications","packages":2,"applications":["BLA125293"],"identity":{"application_numbers":["BLA125293"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2010-09-14","latest":"2025-08-29","packages_with_a_start_date":2}},"label_history":{"events_total":13,"non_cmc_events":13,"counts_by_class":{"LABELING":10,"EFFICACY":1,"REMS":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA125293","submission_no":116,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-07","documents":[{"type":"Letter","date":"2026-08-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125293Orig1s116ltr.pdf","untrusted":true}}],"fact_id":"0a81364c34c5de6a30150a46"},{"application":"BLA125293","submission_no":104,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-07-07","documents":[{"type":"Letter","date":"2022-07-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125293Orig1s104ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-07-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125293s104lbl.pdf","untrusted":true}}],"fact_id":"93cf988552532064bac83547"},{"application":"BLA125293","submission_no":92,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-07-13","documents":[{"type":"Letter","date":"2018-07-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125293Orig1s092ltr.pdf","untrusted":true}},{"type":"Label","date":"2018-07-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125293s092lbl.pdf","untrusted":true}}],"fact_id":"8f0f07a455393163a65d3d09"},{"application":"BLA125293","submission_no":90,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-08-10","documents":[],"fact_id":"27d46db39d4aa9b291c63706"},{"application":"BLA125293","submission_no":89,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-09-09","documents":[{"type":"Letter","date":"2016-09-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s089ltr.pdf","untrusted":true}},{"type":"Label","date":"2017-01-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s089lbl.pdf","untrusted":true}}],"fact_id":"6e8d08c870f4cb3d9afc6199"}],"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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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:BLA125293","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":"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."}