Eton gets FDA green light for Alkindi Sprinkle

Eton Pharmaceuticals has received the Food and Drug Administration’s blessing for Alkindi Sprinkle (hydrocortisone) oral granules as replacement therapy for adrenocortical insufficiency in children under 17 years old.

Alkindi Sprinkle is the first and only FDA approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children, the company said.

“The FDA approval of Alkindi Sprinkle is a breakthrough for patients and caregivers treating pediatric adrenocortical insufficiency. We are excited to offer an FDA-approved product that enables low dosing and administration of hydrocortisone to pediatric patients,” said Eton CEO Sean Brynjelsen. 

The company expects the product to be available in the fourth quarter of 2020.