{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-23-018467","form_type":"8-K","ticker":"CPIX","cik":"0001087294","company_name":"CUMBERLAND PHARMACEUTICALS INC","filed_at":"2023-05-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.900920+00:00","generated_at":"2026-06-14T23:11:31.204427+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA approves Caldolor for infants aged 3-6 months; only injectable non-opioid for pain/fever in that age group","bullets":["FDA approval expands Caldolor label to include infants 3 months to 6 months for pain and fever.","Caldolor is now the only injectable non-opioid approved for pain treatment in infants.","Approval based on a multi-center study in 21 hospitalized infants; safety and efficacy established from age 3 months.","The company expects Caldolor to be eligible for special Medicare reimbursement under the NOPAIN Act."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-23-018467","json":"https://secwatch.observer/filing/0001628280-23-018467.json","markdown":"https://secwatch.observer/filing/0001628280-23-018467.md","text":"https://secwatch.observer/filing/0001628280-23-018467.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1087294/000162828023018467/0001628280-23-018467-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1087294/000162828023018467/cpix-20230516.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T23:11:31.204427+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}