FDA Approval for IMPAVIDO issued to ETON
FDA approved SUPPL-9 labeling (package insert) for ETON's IMPAVIDO (miltefosine 50mg capsule) on 11/02/2026; no new indication.
What this release says
The FDA approved a labeling supplement, SUPPL-9, for ETON's IMPAVIDO (miltefosine 50 MG capsules) on 11/02/2026, according to the agency's records. The filing lists the update as a package insert change and does not describe what the revised label says. For a shareholder, this is a routine regulatory housekeeping step rather than a new indication or a new drug approval.
Key figures
- Approval action date
- 11/02/2026
- Strength
- 50MG
- Application number
- 204684
Positive for shareholders
- The FDA approved the supplement, which keeps IMPAVIDO's marketing approval in place.
Written by Quantisnow AI from this release. Not financial advice.
Key terms
- NDA:
- New Drug Application, the formal request a company files with the FDA to market a drug in the United States.
- Labeling supplement:
- A change to a drug's approved label, such as the package insert, submitted to the FDA after the original approval.
- Orphan:
- A designation given by the FDA to drugs for rare diseases, which can bring development incentives.
FAQ
What did the FDA approve for ETON's IMPAVIDO?
The FDA approved supplement SUPPL-9 under the Labeling-Package Insert category on 11/02/2026, according to the agency listing for NDA 204684.
Does this approval add a new use for IMPAVIDO?
The filing does not say what changed in the label, and it only identifies the supplement as a package insert labeling change.
Historical context for ETON
Across the 26 sessions after earlier ETON headlines, the stock closed higher 18 times and lower 8 times, with a median move of 3.0% in either direction. This shows timing only: many things move a stock in a session, and these figures do not show that any headline caused a move.
| Session | Earlier headline | ETON | SPY |
|---|---|---|---|
| Nov 2, 2026 | Eton Pharmaceuticals Announces Licensing and Initiation of ET-900 Program Evaluating Mecasermin/IGF-1 for Treatment of Infantile and Epileptic Spasms | -2.6% | -0.5% |
| Oct 29, 2026 | Eton Pharmaceuticals to Report Third Quarter 2026 Financial Results on Thursday, November 5, 2026 | +3.6% | -0.4% |
| Sep 28, 2026 | Eton Pharmaceuticals Announces U.S. Commercial Availability of IMPAVIDO® (miltefosine) Capsules | +2.6% | -0.7% |
| Aug 27, 2026 | Eton Pharmaceuticals to Participate at 2026 Wells Fargo Healthcare Conference | +0.1% | +0.7% |
| Aug 14, 2026 | Eton Pharmaceuticals Reports Second Quarter 2026 Financial Results | +44.3% | -0.2% |
| Aug 5, 2026 | Eton Pharmaceuticals Expands Infantile Hemangioma Franchise with Acquisition of U.S. Rights to Late-Stage Product Candidate ASN-001 | +0.3% | -0.2% |
Keep researching ETON
- FDA approval processA new drug needs an IND to start human trials and an approved NDA or BLA to be sold. Learn each FDA step, review timelines, expedited programs and what a CRL means.
- ETON insider tradesEvery buy and sale reported by Eton Pharmaceuticals Inc. officers, directors and large holders.
- ETON earnings historyPast Eton Pharmaceuticals Inc. earnings releases, newest first.
- ETON financial statementsRevenue, profit, cash flow and balance sheet from Eton Pharmaceuticals Inc.'s SEC filings.
- Market cap
- 30-day
- Sector
- Health Care
- Industry
- Biotechnology: Pharmaceutical Preparations
- Listed since
- 2018
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