ARTICLE | Clinical News
Advisory committee meeting Oct. 12 to discuss NDA for Acelrx's Dsuvia
September 13, 2018 10:43 PM UTC
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet Oct. 12 to discuss an NDA from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) for Dsuvia sufentanil sublingual tablet (ARX-04) to manage moderate to severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults in a medically supervised setting. The NDA has a Nov. 3 PDUFA date.
In October 2017, AcelRx received a complete response letter for Dsuvia (see “AcelRx’s Dsuvia Gets CRL”)...
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