Eton Pharmaceuticals, Inc. 8K

Eton Pharmaceuticals submitted a Prior Approval Supplement to the FDA to expand KHINDIVI’s pediatric indication after demonstrating bioequivalence of a new formulation to ALKINDI SPRINKLE, targeting potential label expansion in 1H 2027.

Eton Pharmaceuticals, Inc. announced that a new formulation of its FDA‑approved hydrocortisone oral solution KHINDIVI has demonstrated bioequivalence to ALKINDI SPRINKLE and that the company has submitted a Prior Approval Supplement to the U.S. Food and Drug Administration seeking to expand KHINDIVI’s indication to include younger pediatric patients with adrenal insufficiency (currently approved for ages five and older), enabling a potential approval of the expanded label in the first half of 2027 and supporting broader adoption in the approximately 10,000-patient U.S. pediatric adrenal insufficiency market.

Filing Facts

CIK

1710340

Ticker

-

Form

8K

Source Type

sec

Accession

0001437749-26-024746

Alert Tier

6