UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 8.01 Other Events.
Eton Pharmaceuticals received notice from the United Kingdom-based manufacturer of its zonisamide oral suspension product candidate that the United States Food and Drug Administration (“FDA”) has scheduled an on-site inspection of the facility beginning on January 27, 2022. The New Drug Application (“NDA”) for the zonisamide product was previously assigned a target action date of January 29, 2022. While no additional communication has been received from the FDA regarding the target action date, Eton believes the FDA’s decision on the zonisamide product may be received after the current target action date due to the time required to complete and process the facility inspection. Eton continues to believe the inspection of the manufacturing site is the only open item holding up approval of the NDA for the zonisamide product. Upon FDA approval and launch of the product, Eton is entitled to receive a $5 million milestone payment from its partner.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: December 21, 2021 | By: | /s/ W. Wilson Troutman |
| W. Wilson Troutman | ||
| Chief Financial Officer and Secretary | ||
| (Principal Financial Officer) |
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