FDA Approves Adamis’ Pre-Filled Epinephrine Syringe

in Food Allergy, Food Allergy News
Published: June 15, 2017

Adamis pre-filled epinephrine syringe
A new competitor has the green light to enter the epinephrine marketplace.

The U.S. Food and Drug Administration (FDA) has approved Adamis Pharmaceuticals’ pre-filled epinephrine syringe, which goes by brand name Symjepi.

“We are very excited by this approval, and at the same time, are already preparing to submit our second NDA [new drug application] to the FDA,” Dr. Dennis J. Carlo, president and CEO of the company, said in a statement.

“This second submission is for the junior version of Symjepi. We are committed to helping patients by providing them with additional therapeutic choices. ”

Mark Flather, senior director of investor relations and corporate communications at Adamis, touts the device’s portability and ease of use. While he can’t specify the price yet, he suggests it will be attractive for both patients and medical professionals.

“We do anticipate to be positioning this product as the low cost alternative to the current offerings and that includes the authorized generic EpiPen,” Flather told Allergic Living. “There is a lot of room for Adamis to make a decent profit, but also provide competitive pricing. We think there’s a balance there.”

The size of the syringe is about 4 inches long and fits in the “palm of your hand,” according to Flather.

Adamis is anticipating the launch of Symjepi in the second half of the year.

Symjepi is a pre-filled syringe, meaning that one presses down on a plunger to give the medicine via a needle. Auto-injectors, by contrast, contain a spring-loaded syringe to deliver epinephrine.

View the company’s release here.