{"answer":{"query":"Avonex","resolved_as":"applications","packages":4,"applications":["BLA103628"],"identity":{"application_numbers":["BLA103628"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true},{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2003-05-23","latest":"2014-08-29","packages_with_a_start_date":4}},"label_history":{"events_total":22,"non_cmc_events":22,"counts_by_class":{"LABELING":16,"EFFICACY":5,"S":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA103628","submission_no":5269,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-07-28","documents":[{"type":"Label","date":"2023-07-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103628s5269lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-07-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103628Orig1s5269ltr.pdf","untrusted":true}}],"fact_id":"c52cf1e1e816a0335277c982"},{"application":"BLA103628","submission_no":5266,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-11-03","documents":[{"type":"Letter","date":"2021-11-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103628Orig1s5266ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-11-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103628s5266lbl.pdf","untrusted":true}}],"fact_id":"a4aaf4cf5b1ef5a964283f3f"},{"application":"BLA103628","submission_no":5263,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-03-27","documents":[{"type":"Letter","date":"2020-03-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103628Orig1s5263ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103628s5263lbl.pdf","untrusted":true}}],"fact_id":"56c1fed681eb9aa3aad24385"},{"application":"BLA103628","submission_no":5264,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-07-12","documents":[{"type":"Label","date":"2019-07-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103628s5264lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-07-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103628Orig1s5264ltr.pdf","untrusted":true}}],"fact_id":"091c1fa662855e2284914873"},{"application":"BLA103628","submission_no":5258,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-12-22","documents":[{"type":"Letter","date":"2015-12-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103628Orig1s5258ltr.pdf","untrusted":true}},{"type":"Label","date":"2015-12-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf","untrusted":true}}],"fact_id":"c3e6e904b58d7b25717587a5"}],"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":"BLA103628","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"AVONEX","untrusted":true},"form":{"text":"VIAL","untrusted":true},"strength":{"text":"30UG/ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0776-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"17a24c111fe890596e388414"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"biologic_status":{"products":[{"application":"BLA103628","status":"Reference","name":{"text":"Avonex","untrusted":true},"proper_name":{"text":"interferon beta-1a","untrusted":true},"license_status":"Licensed","approval_date":"1996-05-17","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":"888112eebeaad24b015d4383"}],"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":1,"all_states_medicaid_reimbursed_usd":2186472.91,"all_states_medicaid_paid_prescriptions":245,"top_states":[{"state":"CA","medicaid_paid_prescriptions":245,"medicaid_reimbursed_usd":2186472.91,"total_reimbursed_usd":2186472.91,"packages":1,"covers":"all_record_types","fact_id":"58bd5fa5622ed15c68c56513"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":31,"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":"c13f718ec6356b9ea03f90ac","field":"ndc.listing","entity":"ndc:59627000206"},{"fact_id":"9bb1040d129a06c6fc129cc1","field":"ndc.listing","entity":"ndc:59627000301"},{"fact_id":"c93d4da11210ecee6fa8f90b","field":"ndc.listing","entity":"ndc:59627022205"},{"fact_id":"c52cf1e1e816a0335277c982","field":"drug.label_event","entity":"application:BLA103628"},{"fact_id":"a4aaf4cf5b1ef5a964283f3f","field":"drug.label_event","entity":"application:BLA103628"},{"fact_id":"56c1fed681eb9aa3aad24385","field":"drug.label_event","entity":"application:BLA103628"},{"fact_id":"091c1fa662855e2284914873","field":"drug.label_event","entity":"application:BLA103628"},{"fact_id":"c3e6e904b58d7b25717587a5","field":"drug.label_event","entity":"application:BLA103628"},{"fact_id":"e9346ef8d9925d3d666df362","field":"drug.marketing_status","entity":"application:BLA103628"},{"fact_id":"17a24c111fe890596e388414","field":"ndc.recall","entity":"ndc:59627022205"},{"fact_id":"888112eebeaad24b015d4383","field":"drug.biologic_status","entity":"application:BLA103628"},{"fact_id":"58bd5fa5622ed15c68c56513","field":"ndc.medicaid_state_utilization","entity":"ndc_state:59627033304:CA"}],"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:BLA103628","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":"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."}