6 June 2016 - Adamis Pharmaceuticals announced that after the close of the stock markets on 3 June 2016 it received a complete response letter from the U.S. FDA regarding its New Drug Application epinephrine injection USP 1:1000 0.3 mg pre-filled single dose syringe product.

The pre-filled syringe (PFS) of epinephrine is for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction. A complete response letter (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.

Adamis Pharmaceuticals 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. It should be noted that the Company has successfully completed the “volume delivery” issue that was associated with the initial CRL. The FDA has indicated that the NDA will remain open until these issues are resolved.

For more details, go to: http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2175190