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Novel muscle relaxant reverser wins US priority review status

The FDA assigns priority review status to US-based pharmaceutical company Schering-Plough's NDA for sugammadex

The FDA has assigned priority review status to US-based pharmaceutical company Schering-Plough's (S-P) New Drug Application (NDA) for sugammadex.

Sugammadex reverses the effects of US-marketed muscle relaxants, such as Zemuron (rocuronium) and vecuronium, which are used in general anaesthesia during surgical procedures.

If approved, sugammadex will be the first in a new class of drugs known as selective relaxant binding agents which encapsulate the muscle relaxant molecule and render it inactive.

S-P's CMO, Dr Robert Spiegel, said: "Sugammadex has the potential to change the way doctors practice anaesthesia as it will allow anaesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents."

S-P acquired sugammadex through its acquisition of Organon BioSciences on 19 November 2007.

3rd January 2008

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