Merck & Co. has received a Complete Response Letter from FDA for the resubmission of its new drug application for 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.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.