Eton Pharmaceuticals (ETON) said Thursday that the US Food and Drug Administration has extended the review deadline for Eaton's new drug application for ET-400, its proprietary patented formulation of hydrocortisone oral solution.
The new Prescription Drug User Fee Act goal date is May 28.
The FDA informed Eton that more time is needed to review additional information submitted in December. The new deadline reflects a standard three-month extension from the original date of Feb. 28.
"We do not expect this standard extension to significantly affect our internal 2025 revenue projections," Chief Executive Sean Brynjelsen said.
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