NEWS

FDA rejects Adamis Pharma's injection for treating allergic reactions

Saturday, Mar 28, 2015

The United States Food and Drug Administration rejected Adamis Pharmaceuticals Corp's injection for treating severe allergic reactions, the company said on Friday.

The pre-filled epinephrine injection, is being developed to treat acute anaphylaxis, a severe allergic reaction that can cause death.

Adamis said the questions raised by the FDA largely pertained to the volume of the dose delivered by the pre-filled injection.

The company said it would meet with the FDA to discuss the future of the product.

 

reuters.com