ETON PHARMACEUTICALS, INC. : Other Events, Financial Statements and Exhibits (form 8-K)

Item 8.01 Other Events.

On January 11, 2023, Eton Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) response for dehydrated alcohol injection for the proposed indication of methanol poisoning. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2023.

Eton's application has previously been granted orphan drug designation for the indication of methanol poisoning and if approved, the Company expects the FDA to grant the application seven years of orphan drug exclusivity. Based on IQVIA data, trailing twelve month sales for dehydrated alcohol injection were $74 million.

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits

Exhibit 99.1     Press Release dated January 11, 2023
104            Cover Page Interactive Data File (embedded within the Inline XBRL
               document)




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