Adamis Pharmaceuticals Corp. announced resubmission of its epinephrine pre-filled syringe NDA for emergency treatment of anaphylaxis on Dec. 16. FDA had issued its second CRL for the epinephrine PFS product in June 2016, calling for expanded human factor study and reliability testing related to product improvements made in response to the agency's first CRL. (Also see "Keeping Track: KemPharm Apadaz Delay; Cholera Vaccine Approved" - Pink Sheet, 13 June, 2016.) Lack of competition in the emergency epinephrine marketplace has contributed to Mylan Pharmaceuticals Inc.'s controversial pricing for EpiPen. (Also see "Why Generic EpiPen Is Not The Answer – Until FDA Says It Is" - Pink Sheet, 29 August, 2016.)

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