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Epinephrine Pre-filled Syringe (PFS) - single dose

The Epinephrine Pre-filled Syringe (PFS) (Epinephrine Injection USP 1:1000, 0.3mg Pre-Filled Single Dose Syringe) intends to compete as a simpler, more intuitive, low-cost therapeutic alternative to epinephrine auto injectors like the well-known brand EpiPenĀ®1 in the anaphylaxis market. The Company filed its 505(b)(2) application with the FDA in May of 2014.

Addressable Market ~ $1.1 billion

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.

1EpiPenĀ® is a registered trademark of Mylan Inc. Mylan Inc. does not sponsor or endorse the products referenced on this web page.