Posted by Michael Wonder on 29 Sep 2020
Eton Pharmaceuticals announces FDA approval of orphan drug Alkindi Sprinkle (hydrocortisone) as replacement therapy in paediatric patients with adrenocortical insufficiency
29 September 2020 - Alkindi Sprinkle is the first and only FDA approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children.
Eton Pharmaceuticals today announced that the U.S. FDA has approved Alkindi Sprinkle (hydrocortisone) oral granules as replacement therapy for adrenocortical insufficiency in children under 17 years of age.
The FDA approval of Alkindi Sprinkle was supported by six clinical studies, including the first and only interventional Phase 3 trial of oral hydrocortisone for paediatric adrenocortical insufficiency in neonates to children under eight years of age.
