UPDATE 1-US FDA approves Eton Pharma's hormonal disorder drug

Eton Pharmaceuticals, Inc.

Eton Pharmaceuticals, Inc.

ETON

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- The U.S. Food and Drug Administration approved on Wednesday Eton Pharmaceuticals' ETON.O oral liquid therapy for a rare childhood hormonal disorder, giving families an easier way to manage the condition and keep children hydrated.

The drug, Desmoda, is a proprietary, patented oral formulation of desmopressin for treating central diabetes insipidus, or arginine vasopressin deficiency (AVP-D), a rare disorder in which the body lacks the hormone that regulates water balance, causing excessive urination and thirst.

The approval helps address a long‑standing challenge in managing the condition, where doctors must carefully adjust dosing to keep water levels stable and prevent dangerous shifts in sodium, especially in children.

Eton expects Desmoda to generate annual peak sales in the range of $30 million to $50 million.