Ology Bioservices and Rafa Laboratories announced they received full approval from the U.S. Food and Drug Administration (FDA) for the Atropine Injection, 2mg/0.7mL, Single-Dose Autoinjector. The Atropine Autoinjector initially received Emergency Use Authorization from the FDA in April 2017. Atropine is one of the most commonly used drugs for the treatment of chemical nerve agent poisoning. With the approved autoinjector, U.S. troops can rapidly inject atropine into the thigh muscle following nerve agent exposure.
This FDA approval decreases reliance on a sole source drug product and device manufacturer and ensures that the Department of Defense (DoD), U.S. Government stakeholders, and international partners can quickly and cost-effectively procure the Atropine Autoinjector in the event of a nerve agent threat. There is substantial potential for a public health emergency involving nerve agents and certain insecticides. The usage of these agents can affect national security as well as the health and security of U.S. citizens living abroad.
The Joint Project Management Office for Medical Countermeasure Systems (JPM-MCS) Chemical Defense Pharmaceuticals (CDP) Project Management Office, funded and led the collaboration for development of the Atropine Autoinjector, which also included the FDA, Centers for Disease Control and Prevention (CDC) and Battelle.
“FDA approval of the Atropine Autoinjector serves to further demonstrate the strength of our expertise, as well as our ongoing commitment to bringing medical countermeasures to the U.S. military,” said Dr. Doris Snow, Vice President, Global Regulatory Affairs at Ology Bioservices. “Moreover, having worked successfully alongside Rafa since 2015, we are delighted to have the opportunity to expand this important partnership as the company’s U.S. Agent.”