FDA Week - 11/09/2018

FDA Okays Controversial Sufentanil Drug As Gottlieb Addresses Criticisms

November 02, 2018
Despite opposition from public health advocacy groups and the chair of one of its own advisory committees, FDA on Friday (Nov. 2) approved a new sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl, while promising to revisit how it reviews new opioids moving forward. This marks the first product approved for acute pain severe enough to require an opioid analgesic, and FDA chief Scott Gottlieb put out a lengthy statement addressing the criticisms...

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