Merck: FDA reviewing re-filed drug for surgery
WHITEHOUSE STATION, N.J. (AP) — Federal regulators are taking another look at Merck & Co.'s experimental drug for reversing effects of anesthesia after surgery, the drugmaker said Monday.
If approved, sugammadex would be the first in a new class of medicines in the U.S. for reversing effects of certain drugs that relax muscles during surgery.
This is Merck's second attempt to get approval for the injected drug. The Food and Drug Administration rejected it in 2008 over concerns about allergic reactions and bleeding in some participants in clinical studies.
Merck, based in Whitehouse Station, N.J., later submitted additional information requested by the FDA. The company said it now expects the review to be completed in the first half of this year.
Sugammadex is one several drugs for which Merck plans to seek approval in 2013.
Merck shares rose 6 cents to $42.03 in midday trading. Its shares have traded in a 52-wek range of $36.91 to $48.