- According to an SEC filing, the FDA action date for Eton Pharmaceuticals Inc's (NASDAQ:ETON) antiepileptic topiramate oral solution has been delayed three months to November 6.
- An FDA decision was expected on Friday.
- However, Eton said that privately held Azurity Pharmaceuticals submitted a recent amendment to the drug application.
- Topiramate is one of three neurology candidates Azurity purchased from Eton in February.
- If approved, Eton is entitled to a $5M milestone payment and a royalty on sales.
- Eton suffered a setback in late May when FDA declined to approve the Company's dehydrated alcohol injection for methanol poisoning.
- Price Action: ETON stock is down 16.4% at $4.91 on the last check Monday.
- Related content: Benzinga's Full FDA Calendar.
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