On Monday, shares of Adamis Pharmaceuticals Corp. ADMP are crashing, down over 50% in morning trading after news broke that the Food and Drug Administration (FDA) sent the company a Complete Response Letter (CRL) about its New Drug Application of Epinephrine Injection USP 1:1000, 0.3mg Pre-Filled Single Dose Syringe (Epinephrine Pre-Filled Syringe).
A CRL is usually issued after the FDA has completed its review of a NDA, but there still remains unanswered questions or doubts, keeping the FDA from approving the drug in its current form. Adamis initially received a CRL on March 27, 2015, when the FDA pointed out that the company needed to increase its human factors (patient usability) and reliability (product stress testing) studies.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We look forward to working with the FDA to resolve the remaining issues. Our goal is to submit the protocols for these studies to the FDA within a matter of weeks and begin the testing as soon as we receive their feedback. We are confident that we can deliver all of the data requested by FDA and will continue to work closely with the agency to facilitate their continued review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market.”
The Epinephrine Pre-Filled Syringe is an emergency treatment for acute anaphylaxis, or a severe allergic reaction.
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