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Anonymous ID: 1cfddb March 4, 2022, 10:47 p.m. No.15787201   🗄️.is 🔗kun   >>7230 >>7254 >>7426 >>7542

FDA Approves Kaléo’s 10 mg Naloxone Auto-Injector for the Treatment of Known or Potential Exposure to Ultra-Potent Weaponized Opioids

 

RICHMOND, Va.(BUSINESS WIRE)Kaléo, a privately held U.S. pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Naloxone Auto-injector 10 mg (NALOXONE HYDROCHLORIDE injection) indicated for the emergency treatment of people 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon, is suspected. See full indication below.

 

“Kaléo was selected by the Department of Defense to design and manufacture the Rapid Opioid Countermeasure System for military personnel and chemical incident responders. We are pleased to have delivered the product under budget, and five months ahead of schedule, despite challenges presented by the COVID-19 global pandemic”

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Additionally, the Naloxone Auto-injector 10 mg is indicated for the temporary prevention (prophylaxis) of either breathing problems (respiratory depression), decreased brain and nerve function (central nervous system depression), or both, in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.

 

The product was developed for the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in collaboration with the Chemical and Biological Defense Program (CBDP). The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s CBRN response capability.

 

https://www.businesswire.com/news/home/20220302005211/en/