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news.The US Food and Drug Administration (FDA) has accepted for review Adamis Pharmaceuticals' new drug application (NDA) for the product, Epinephrine Injection, USP, 1:1000 (0.3mg Pre-filled single dose syringe) (PFS), for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
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The company’s PFS is designed as a low cost alternative to other auto-injectors in the market and it offers two single dose syringes of epinephrine, which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, foods, drugs and other allergens, as well as idiopathic or exercised-induced anaphylaxis.
Adamis president and CEO Dennis Carlo said this is a major milestone in that the PFS will be the company’s first product to generate revenues.
"With the FDA’s acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for the PFS in the U.S. in the first half of 2015," Carlo said.
Anaphylaxis is a serious, sometimes life-threatening allergic reaction and the most common anaphylactic reactions are to foods, insect stings, medications and latex.