July 16, 2013 / 4:16 PM / in 5 years

Merck says FDA needs more time to complete sugammadex review

July 16 (Reuters) - Merck & Co Inc said on Tuesday that U.S. health regulators need more time to review its application to sell sugammadex, an injection designed to reverse the effects of muscle relaxants used during surgery.

The announcement came after the U.S. Food and Drug Administration canceled a meeting of outside advisers that had been set for Thursday. Merck said the FDA told the company it needed additional time to assess the results of its recently completed inspection of one of Merck’s clinical trial sites.

In 2008 the FDA declined to approve sugammadex, citing concerns about its possible association with allergic reactions and bleeding. On Tuesday, Merck said the site in question was one of four that conducted a new study designed to assess the drug’s potential to cause allergic reactions.

Merck acquired sugammadex when it bought Schering-Plough for $41 billion in 2009.

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