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S-P’s NDA Gets Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Schering-Plough’s NDA for sugammadex has been assigned priority review status by the FDA. Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the U.S. as Zemuron and vecuronium bromide, which are used as part of general anesthesia.

“Organon, now part of Schering-Plough Corporation, has had a strong presence in the anesthesia market for over 35 years,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “The development of sugammadex is an exciting advance for the practice of anesthesia. This novel drug has the potential to change the way doctors practice anesthesia as it will allow anesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents.”

Schering-Plough acquired sugammadex through its combination with Organon BioSciences in November 2007.

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