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news.EMD Pharmaceuticals, a US affiliate of Germany's Merck KGaA, has completed the submission of a new drug application to the FDA for its Cyanokit treatment for cyanide poisoning.
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Cyanokit is in development for the treatment of known or suspected cyanide poisoning and is currently marketed in France by another Merck KGaA affiliate, Merck Sante.
The FDA has previously granted Cyanokit fast track designation, which is intended to facilitate the development of new therapeutic medicines for the treatment of serious or life-threatening conditions with unmet medical needs.
A common and often unrecognized source of cyanide exposure occurs during a fire. Cyanide may be produced by the incomplete burning of common synthetic or plastic materials as well as from natural materials such as wood, paper and silk. According to the company, cyanide is increasingly recognized to be as common and dangerous as carbon monoxide as a fire smoke toxicant.
“As our first NDA filing, this submission marks an important milestone for both the product and our company,” said Nancy Wysenski, president of EMD Pharmaceuticals.