NasdaqGM:ETONPharmaceuticals
Is Eton Pharmaceuticals (ETON) Quietly Reframing Its Orphan-Drug Strategy With KHINDIVI’s Label Expansion Bid?
Eton Pharmaceuticals has submitted a Prior Approval Supplement to the FDA seeking to extend KHINDIVI’s hydrocortisone oral solution label to younger pediatric patients with adrenocortical insufficiency, beyond its current approval for those aged five and older.
This move, backed by bioequivalence data versus ALKINDI SPRINKLE, could broaden treatment options in a rare disease population where Eton estimates about 10,000 U.S. pediatric patients.
With KHINDIVI already the only FDA-approved...