The Committee will discuss a new drug application (NDA 209128) for sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The Committee will also be asked to discuss risk-benefit considerations and whether this product should be approved.
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Earlier Event: October 11Anesthetic and Analgesic Drug Products Advisory Committee
Later Event: October 16Secretary's Advisory Committee on Human Research Protections