UPDATE 1-Merck expects to be denied approval for sugammadex injection again

March 13, 2015 9:36 PM

6 0

March 13 (Reuters) - Merck & Co Inc said it expects its long-delayed drug to reverse the effects of anesthesia to be denied U.S. approval after U.S. regulators said they need to conduct more site inspections related to a study of the drug.

Merck on Friday said it expects a so-called complete response letter from the U.S. Food and Drug Administration by April 22. Such letters indicate that the agency is unwilling to approve a drug until certain conditions are met.

Read more

To category page

Loading...