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

First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines

Click here