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Sugammadex FDA Review Documents – Doctor Getafix

Sugammadex FDA Review Documents

I was recently clearing out my “Downloads” folder (which had got way out of hand!), and while doing so I found a document I’d downloaded in July 2019 when I was looking into the light-sensitivity of sugammadex. It was part of an FDA review into the drug when it was being considered for approval in the United States. It just so happened this discovery came in the middle of a Twitter discussion on the potential for sugammadex to cause, amongst other things, anaphylaxis.

This document had a fair bit to say on the topic of anaphylaxis, so I did a bit more digging and found several other documents relating to that FDA review. They are very long, and I’ve only had a cursory look at a couple of them, but I thought storing them in one place could be helpful for future reference, and also to make it easy to share them with others who might be interested in taking a deep dive into the topic.

  1. “Approval Package”
  2. “Clinical Pharmacology and Biopharmaceutics Review(s)”
  3. “Medical Review(s)”
  4. “Risk Assessment and Risk Mitigation Review(s)”
  5. “Statistical Review(s)”
  6. “Other Review(s)”
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