secwatch.observer — SEC 8-K summary
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Issuer:     Eton Pharmaceuticals, Inc. (ETON)
CIK:        0001710340
Form:       8-K
Filed at:   2024-04-30T23:59:59+00:00
Accession:  0001437749-24-013838
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Eton submits NDA to FDA for ET-400 hydrocortisone oral solution; approval expected Q1 2025
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- NDA submitted for ET-400, a proprietary patented hydrocortisone oral solution.
- Company expects 10-month FDA review; potential approval and launch in Q1 2025.
- Combined peak sales of ET-400 and Alkindi Sprinkle forecast to exceed $50M annually.
- ET-400 has patent protection through 2043; additional patent applications under review.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1710340/000143774924013838/0001437749-24-013838-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1710340/000143774924013838/eton20240426c_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-013838

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