{"answer":{"query":"Serostim","resolved_as":"applications","packages":3,"applications":["BLA020604"],"identity":{"application_numbers":["BLA020604"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"1996-08-23","latest":"1997-07-25","packages_with_a_start_date":3}},"label_history":{"events_total":51,"non_cmc_events":19,"counts_by_class":{"LABELING":17,"EFFICACY":2},"cmc_events":32,"recent_non_cmc_events":[{"application":"BLA020604","submission_no":104,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-07-14","documents":[{"type":"Letter","date":"2026-07-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020604Orig1s104ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020604s104lbl.pdf","untrusted":true}}],"fact_id":"26451cb26543e0ca419d4d8c"},{"application":"BLA020604","submission_no":74,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-05-24","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020604Orig1s074ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s074lbl.pdf","untrusted":true}}],"fact_id":"7fa7f2a92d961842e112b6d8"},{"application":"BLA020604","submission_no":93,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-05-09","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020604Orig1s093ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-03-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s093lbl.pdf","untrusted":true}}],"fact_id":"a00ad6fa122ba03597675444"},{"application":"BLA020604","submission_no":90,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-12-13","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020604Orig1s090ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s090lbl.pdf","untrusted":true}}],"fact_id":"0a8846a588658ba2b395268d"},{"application":"BLA020604","submission_no":89,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-12-13","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020604Orig1s089ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s089lbl.pdf","untrusted":true}}],"fact_id":"fb44c205317d2f6898c90ea5"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"NOT_PROVIDED":5},"marketing_status_counts":{"Discontinued":2,"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":"BLA020604","product_no":"004","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"SEROSTIM","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"8.8MG/VIAL","untrusted":true}},{"application":"BLA020604","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SEROSTIM","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"5MG/VIAL","untrusted":true}},{"application":"BLA020604","product_no":"005","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"SEROSTIM LQ","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"6MG/0.5ML (6MG/0.5ML)","untrusted":true}},{"application":"BLA020604","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SEROSTIM","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"4MG/VIAL","untrusted":true}},{"application":"BLA020604","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SEROSTIM","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"6MG/VIAL","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Somatropin","untrusted":true},"brand":{"text":"Serostim","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":102791575.24,"claims":6139,"beneficiaries":693,"average_spending_per_claim_usd":16744.025939,"fact_id":"3bfd1bc67f748d23a431fbfb"},{"year":2021,"gross_spending_usd":101164044.57,"claims":5560,"beneficiaries":623,"average_spending_per_claim_usd":18194.972045,"fact_id":"dc6757f2950d688063f9ce1a"},{"year":2022,"gross_spending_usd":104635732.54,"claims":5433,"beneficiaries":597,"average_spending_per_claim_usd":19259.291835,"fact_id":"28c51fdb1367cbe3450b4739"},{"year":2023,"gross_spending_usd":107368289.71,"claims":5192,"beneficiaries":604,"average_spending_per_claim_usd":20679.562733,"fact_id":"2941ff760fbdcb2f1f99c8a8"},{"year":2024,"gross_spending_usd":109515830.01,"claims":5396,"beneficiaries":612,"average_spending_per_claim_usd":20295.743145,"fact_id":"6307d5bf13dc13309f23d2c6"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"biologic_status":{"products":[{"application":"BLA020604","status":"Reference","name":{"text":"Serostim; Zorbtive/Serostim","untrusted":true},"proper_name":{"text":"somatropin","untrusted":true},"license_status":"Licensed; Voluntarily Revoked","approval_date":"1996-08-23","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":"3e527d300876a17e62791e7a"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Somatropin","untrusted":true},"designation_count":8,"approved_count":5,"recent":[{"designated":"2006-08-09","use":{"text":"Treatment of short stature in patients with Noonan syndrome","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novo Nordisk Inc.","untrusted":true},"approved":true},{"designated":"2005-12-15","use":{"text":"Treatment of short stature in pediatric patients with short stature homeobox-containing gene (SHOX) deficiency","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Eli Lilly and Company","untrusted":true},"approved":true},{"designated":"2004-03-16","use":{"text":"Treatment of patients with HIV-associated adipose redistribution syndrome","untrusted":true},"status":"Designated","sponsor":{"text":"EMD Serono, Inc.","untrusted":true},"approved":false},{"designated":"1994-09-06","use":{"text":"Treatment of adults with growth hormone deficiency.","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Pharmacia & Upjohn","untrusted":true},"approved":true},{"designated":"1993-02-12","use":{"text":"Treatment of cachexia associated with AIDS.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Bio-Technology General Corp.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"148112e5101b6bd746b95c5d"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2024,"states_with_data":2,"all_states_medicaid_reimbursed_usd":3778188.44,"all_states_medicaid_paid_prescriptions":216,"top_states":[{"state":"CA","medicaid_paid_prescriptions":130,"medicaid_reimbursed_usd":2074170.3,"total_reimbursed_usd":2074170.3,"packages":1,"covers":"all_record_types","fact_id":"f202548d8d495d68443678d5"},{"state":"NY","medicaid_paid_prescriptions":86,"medicaid_reimbursed_usd":1704018.14,"total_reimbursed_usd":1704018.14,"packages":1,"covers":"all_record_types","fact_id":"a1ebf624372eb73aa69310cb"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":394,"medicaid_reimbursed_usd":7082454.22,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":3,"facts_fee_for_service_only":0,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","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":"dda1a7d1053250cd75549fe9","field":"ndc.listing","entity":"ndc:44087000407"},{"fact_id":"0848ae413bebcfb3067e9fe4","field":"ndc.listing","entity":"ndc:44087000507"},{"fact_id":"cc50cb2e686cf194f1141c46","field":"ndc.listing","entity":"ndc:44087000607"},{"fact_id":"26451cb26543e0ca419d4d8c","field":"drug.label_event","entity":"application:BLA020604"},{"fact_id":"7fa7f2a92d961842e112b6d8","field":"drug.label_event","entity":"application:BLA020604"},{"fact_id":"a00ad6fa122ba03597675444","field":"drug.label_event","entity":"application:BLA020604"},{"fact_id":"0a8846a588658ba2b395268d","field":"drug.label_event","entity":"application:BLA020604"},{"fact_id":"fb44c205317d2f6898c90ea5","field":"drug.label_event","entity":"application:BLA020604"},{"fact_id":"adbd340f799892e5348829f4","field":"drug.marketing_status","entity":"application:BLA020604"},{"fact_id":"5fb6c351b1ee91a43bea0563","field":"drug.marketing_status","entity":"application:BLA020604"},{"fact_id":"56af14b8e9b0cbd487510c9e","field":"drug.marketing_status","entity":"application:BLA020604"},{"fact_id":"30418ab1ed60ec744aa6526d","field":"drug.marketing_status","entity":"application:BLA020604"},{"fact_id":"06d314052aa6e34ecc1765d3","field":"drug.marketing_status","entity":"application:BLA020604"},{"fact_id":"3bfd1bc67f748d23a431fbfb","field":"drug.partd_spending","entity":"drug:somatropin|serostim"},{"fact_id":"dc6757f2950d688063f9ce1a","field":"drug.partd_spending","entity":"drug:somatropin|serostim"},{"fact_id":"28c51fdb1367cbe3450b4739","field":"drug.partd_spending","entity":"drug:somatropin|serostim"},{"fact_id":"2941ff760fbdcb2f1f99c8a8","field":"drug.partd_spending","entity":"drug:somatropin|serostim"},{"fact_id":"6307d5bf13dc13309f23d2c6","field":"drug.partd_spending","entity":"drug:somatropin|serostim"},{"fact_id":"3e527d300876a17e62791e7a","field":"drug.biologic_status","entity":"application:BLA020604"},{"fact_id":"148112e5101b6bd746b95c5d","field":"drug.orphan_designation","entity":"drug:somatropin"},{"fact_id":"f202548d8d495d68443678d5","field":"ndc.medicaid_state_utilization","entity":"ndc_state:44087000607:CA"},{"fact_id":"a1ebf624372eb73aa69310cb","field":"ndc.medicaid_state_utilization","entity":"ndc_state:44087000607:NY"}],"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:BLA020604","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":"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":"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."}