King Pharmaceuticals Inc has received U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) covering pediatric and adult formulations of the Company's nerve gas antidote AtroPen (atropine). AtroPen utilizes King's auto-injector technology acquired in the January 2003 acquisition of Meridian Medical Technologies Inc.
Kyle P. Macione, President of King, stated, "We are very pleased to receive FDA approval of our sNDA covering pediatric and adult formulations of our nerve gas antidote AtroPen. Our receipt of this approval is particularly significant in that this is the first time that pediatric formulations of this critically important homeland security product have been approved for use in the United States." Macione added, "AtroPen is the first product to emerge from the pipeline of products we acquired as part of our acquisition of Meridian. We are confident that King's established capabilities should continue to expand the prospects for the potential development of other new and innovative products utilizing Meridian's pre-eminent auto-injector technology."
AtroPen is indicated as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings. Each pre-filled auto-injector provides a dose of the antidote atropine, an anticholinergic drug that reduces secretions in the mouth and respiratory passages, relieves the constriction and spasm of respiratory passages, and may reduce the paralysis of respiration, which results from actions of the toxic agent on the central nervous system. AtroPen will be available in three dosage forms: 2mg for adults and children weighing over 90 lbs. (generally over 10 years of age); 1mg for children weighing 40 to 90 lbs. (generally 4 to 10 years of age); and 0.5mg for children weighing 15 to 40 lbs. (generally 6 months to 4 years of age). Pediatric formulations of AtroPen should be available beginning in the fourth quarter of 2003. The adult strength of the Company's nerve gas antidote is presently primarily sold to the U.S. Department of Defense pursuant to a Base Maintenance Contract.