King Pharmaceuticals Receives DHS Safety Act Designation and Certification for AtroPen
AtroPen(R) is a prefilled, ready-to-use, auto-injector containing atropine - an antidote for organophosphorus poisoning. Atropine is widely known and trusted by the medical community and clinically accepted worldwide as a nerve agent antidote. AtroPen(R) is designed for the quick intramuscular administration of a precise dose of atropine to treat symptoms of chemical nerve agent poisoning, as well as toxic levels of common organophosphorous insecticides. AtroPen(R) currently is used by the U.S. Department of Defense and allied nations, as well as emergency medical services (EMS) personnel in the United States.
As part of the Homeland Security Act of 2002, Congress enacted the SAFETY Act to encourage the development and installation of anti-terrorism technologies that significantly improve the protection of our country. Specifically, the SAFETY Act designation and certification are designed to support effective technologies aimed at preventing, detecting, identifying or deterring acts of terrorism - or limiting the harm that such acts might otherwise cause - in addition to meeting other prescribed criteria.(1)
"We are very proud to receive the SAFETY Act designation and certification for AtroPen(R)," said Dennis O'Brien, President of King's Meridian auto-injector business. "This recognition by the DHS validates AtroPen(R) as an effective counter-terrorism technology."
To obtain SAFETY Act designation and certification, companies are required to formally apply to the DHS, provide the requisite supporting data and information, and successfully demonstrate compliance with the Act's specific criteria. DHS then performs a comprehensive evaluation to deem technologies eligible.
King plans to submit applications to the DHS for other similar auto-injector technologies: DuoDote(TM) (single, dual-chambered auto-injector containing two separate antidotes for organophosphorus poisoning, atropine and pralidoxime chloride); and the Mark I(TM) Nerve Agent Auto-Injector Kit (two separate auto-injectors, one containing atropine and one containing pralidoxime chloride, both antidotes for organophosphorus poisoning).
Important Safety information: Individuals should not rely solely upon antidotes such as atropine to provide complete protection from chemical nerve agents and insecticide poisoning. Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use. AtroPen(R) Auto-Injector, Mark I(TM) Nerve Agent Kit (NAAK), and DuoDote(TM) Auto-Injector should be administered by emergency medical services personnel who have had adequate training in the recognition and treatment of nerve agent or insecticide poisoning and the warnings and precautions associated with nerve agent antidote usage. These Auto-Injectors are intended as initial treatment for organophosphorous insecticide or nerve agent poisonings; definitive medical care should be sought immediately. Evacuation and decontamination procedures should be undertaken as soon as possible. Medical personnel assisting evacuated victims of nerve agent poisoning should avoid contaminating themselves by exposure to the victim's clothing.
The full Prescribing Information for these products may be obtained by visiting http://www.meridianmeds.com/homeland.html.
The U.S. Food and Drug Administration (FDA) has approved AtroPen(R) in four pharmaceutical doses: 0.25mg delivered in 0.3mL pyrogen-free sterile solution; and 0.5mg, 1mg and 2mg doses delivered in 0.7mL pyrogen-free sterile solution. AtroPen(R) is designed to deliver medication through clothing and outer garments, including specialized personal protective ensembles worn by emergency responders. The auto-injector requires no preparation prior to use, and the technology is proven and reliable.
Approved by the FDA, King's chemical nerve agent antidote auto-injectors have been supplied to the U.S. Department of Defense and allied nations since the 1950s, and to emergency responders in the U.S. since 1995. Additionally, King has distributed a number of drug formulations, in its proprietary auto-injectors, to more than 30 countries for the emergency treatment of the victims of a chemical nerve agent poisoning.
About King Pharmaceuticals
King, headquartered in Bristol, Tenn., is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
(1)Department of Homeland Security SAFETY Act Web site, www.safetyact.gov.
King Pharmaceuticals, Inc.
James E. Green, 423-989-8125
Executive Vice President, Corporate Affairs
David E. Robinson, 423-989-7045
Senior Director, Corporate Affairs
Porter Novelli Public Relations
Shannon Caudill, 312-856-8892
Posted: May 2007
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