{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-046525","form_type":"8-K","ticker":"ELTP","cik":"0001053369","company_name":"ELITE PHARMACEUTICALS INC /NV/","filed_at":"2024-11-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:07.511342+00:00","generated_at":"2026-05-29T22:52:59.560886+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Elite Pharma gets FDA nod for generic Vyvanse; $4.3B market","bullets":["Received FDA approval on November 15, 2024 for ANDA for generic Lisdexamfetamine Dimesylate (Vyvanse) in 7 strengths (10-70 mg capsules).","Product indicated for ADHD; marketed under Elite Laboratories label.","IQVIA reported annual sales of $4.3B for brand and generic market (12 months ending September 2024)."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-046525","json":"https://secwatch.observer/filing/0001493152-24-046525.json","markdown":"https://secwatch.observer/filing/0001493152-24-046525.md","text":"https://secwatch.observer/filing/0001493152-24-046525.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1053369/000149315224046525/0001493152-24-046525-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1053369/000149315224046525/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T22:52:59.560886+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"}