Eton Pharmaceuticals announces FDA approval

DEER PARK - Eton Pharmaceuticals Inc. said the U.S. Food and Drug Administration has approved its new granular hydrocortisone formula to treat a rare genetic disease in children. Its Alkindi Sprinkle oral granules will soon be available to treat adrenocortical insufficiency, or AI, for children younger than 17.

Pediatric adrenocortical insufficiency is characterized by an inability to synthesize and release cortisol, and sometimes aldosterone. This can cause abnormal sexual development in females, premature puberty, premature growth termination and short stature.

Prior to the approval of Alkindi Sprinkle, oral hydrocortisone was only FDA-approved in tablet formulations of 5 milligrams and stronger. Many pediatric patients require significantly lower doses and more flexibility, the company said.

"For years, we heard from parents about their struggle to provide the right dose to their child," said Dina M. Matos, executive director of the CARES Foundation.