Here is a bit from BioPharmaDive, on it:
. . . .Seven months ago, Bridion was rejected by the FDA's reviewing panel for the third time. The concern was 'hypersensitivity' to the drug, and because the drug had already been used in the E.U. for some time, there were numerous case reports to attest to this risk. . . .
The FDA is not bound by the committee’s guidance but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of Bridion is December 19, 2015. . . .
It is (in my opinion) probable that the US label-copy will contain strong warnings -- about watching for patients' allergic reactions while under heavy sedation, in the OR. Onward, we go, in any event -- on a perfect fall Monday afternoon!
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