secwatch.observer — SEC 8-K summary
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Issuer:     ELITE PHARMACEUTICALS INC /NV/ (ELTP)
CIK:        0001053369
Form:       8-K
Filed at:   2024-11-18T23:59:59+00:00
Accession:  0001493152-24-046525
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Elite Pharma gets FDA nod for generic Vyvanse; $4.3B market
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- 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).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1053369/000149315224046525/0001493152-24-046525-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1053369/000149315224046525/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-046525

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer