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The Company’s lead pipeline product is the Epinephrine Pre-filled Syringe (PFS) (Epinephrine Injection USP 1:1000, 0.3mg Pre-Filled Single Dose Syringe). The PFS, if approved, intends to compete as a low-cost epinephrine therapeutic alternative in the anaphylaxis market. The Company filed a New Drug Application with the FDA in May of 2014 and the application is still pending.

Potential Indication: Anaphylaxis

Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. According to information published by industry sources, up to 8% of U.S. children under the age of 18 have a food allergy, and approximately 38% of those with a food allergy have a history of severe reactions. Anaphylaxis requires immediate medical treatment, including an injection of epinephrine. The number of prescriptions for epinephrine products has grown annually, as the risk of anaphylaxis and allergic reactions have become more widely understood.

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