Merck & Co. Receives Complete Response Letter From FDA Regarding Sugammadex Sodium Injection - - BioPharm International

ADVERTISEMENT

Merck & Co. Receives Complete Response Letter From FDA Regarding Sugammadex Sodium Injection



Merck & Co., has received a Complete Response Letter from FDA for the resubmission of its new drug application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
The FDA’s letter raised concerns about the operational aspects of a hypersensitivity study that the agency had requested in 2008. Merck is evaluating the Complete Response Letter and expects to be able to determine a path forward in the near future.

As previously disclosed, the FDA cancelled the discussion of sugammadex at the July 18th Anesthetic and Analgesic Drug Products Advisory Committee. At that time, the FDA advised Merck that the agency needed additional time to assess the results of the agency’s recently completed inspection of a clinical trial site conducting the hypersensitivity study.

Sugammadex is currently marketed in more than 50 countries other than the United States. If approved, sugammadex would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the US.

Source: Merck & Co.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

AbbVie/Shire Deal Officially Off
October 20, 2014
Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9
October 20, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Lilly to Close Manufacturing Facility in Puerto Rico
October 17, 2014
BioReliance Introduces New Predictive Assays
October 17, 2014
Author Guidelines

Click here