FDA issues Complete Response Letter for Epinephrine Injection for treatment of acute anaphylaxis.-Adamis Pharma

Adamis Pharmaceuticals Corporation announced that after the close of the stock markets on June 3, 2016 it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) product. PFS is for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction.

A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form. Because of the improvements that were made to the PFS in response to the FDA�s original CRL dated March 27, 2015, the FDA indicated that in order to support approval of the product, the Company must expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA. The Company believes that it can finalize the study protocols with the FDA and complete the additional testing within a relatively short period of time at an immaterial cost, and submit the data back to the FDA sometime in the second half of 2016.