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Adamis Pharmaceuticals Receives CRL for Acute Anaphylaxis Candidate

June 10, 2016

A second FDA complete response letter to Adamis Pharmaceuticals for its acute anaphylaxis candidate requests an extension of its human factors and reliability studies.

The letter asks that Adamis expand its patient usability study and product-stress testing for the epinephrine injection after the company made improvements to the pre-filled syringe in response to an initial CRL. The company had conducted and included these studies in its NDA for the prototype, but did not in a resubmission for its latest iteration of the syringe.

Adamis expects to finalize study protocols and additional testing “within a relatively short period of time.” The company plans to resubmit its NDA in the second half of 2016.

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