FDA requires manufacturer to expand patient usability study and product stress testing.
The FDA has rejected Adamis Pharmaceuticals Corporation’s new drug application for a pre-filled epinephrine injection.
Adamis received a complete response letter concerning its epinephrine injection USP 1:1000 0.3 mg pre-filled single-dose syringe, which is designed for emergency treatment of acute anaphylaxis.
The FDA specified that Adamis must expand its patient usability study and product stress testing before it can provide approval.
The company stated in a press release that it believed it could finalize study protocols with the FDA and complete more testing quickly and submit new data in the second half of 2016.
“We look forward to working with the FDA to resolve the remaining issues,” said Dennis Carlo, MD, president and CEO of Adamis, in a press release. “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 [new drug application].”