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Adamis files new drug application with FDA

San Diego-based Adamis Pharmaceuticals Corp. (Nasdaq: ADMP) announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration for its epinephrine pre-filled single dose syringe (PFS) product.

The epinephrine injection USP 1:1000 is designed for the emergency treatment of allergic reactions (Type 1) including anaphylaxis.

Adamis' PFS provides a single dose of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis. Adamis' PFS is designed to be the low-cost, easy-to-use therapeutic alternative to existing epinephrine auto-injectors.

"We feel this NDA submission represents a major milestone for Adamis,” said Dennis Carlo, president and CEO of Adamis. “The epinephrine market is large and growing and we estimate auto-injector sales in the U.S. this year to approach $1 billion. I believe our PFS could be an affordable substitute for the costly auto-injectors. These types of markets have proven to be cost sensitive and we expect epinephrine to be no different. Our PFS could allow Adamis to generate significant revenues and in time lead to profitability."

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Adamis Pharmaceuticals Corp.

Company Website

11455 El Camino Real
San Diego, CA 92130

Adamis Pharmaceuticals Corp. Executive(s):

Dennis Carlo

  • Chief Executive Officer, President

Robert Hopkins

  • Chief Financial Officer

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