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FDA issues complete response letter for Merck & Co.'s sugammadex


Merck & Co. said Monday that the FDA issued a complete response letter in relation to the company’s resubmitted marketing application for the neuromuscular blockade therapy sugammadex. The drugmaker noted that the regulator «raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008.»

Merck, which said it is evaluating the letter and expects to «determine a path forward in the very near future," is developing sugammadex for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. David Michelson, head of global neuroscience clinical development at Merck Research Laboratories, remarked «we believe sugammadex is an important innovation, and will work closely with the FDA to bring this product to hospitals, surgeons, anaesthesia professionals and patients in the [US].»

In July, the FDA cancelled a planned advisory panel meeting on sugammadex to allow the agency more time to analyse the results of an inspection of a site involved in the requested hypersensitivity study. The regulator declined to approve sugammadex in 2008 and asked Schering-Plough, which owned the therapy until its 2009 merger with Merck, to provide additional information concerning allergic reactions and bleeding events. Merck’s resubmitted application for the drug wasaccepted by the FDA in January this year.

The selective relaxant binding agent sugammadex was approved in Europe in 2008 under the name Bridion and is currently marketed in more than 50 countries.

Source: firstwordpharma.com

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