DURECT Announces FDA Advisory Committee Meeting to Review POSIMIR® for the Treatment of Post-Surgical Pain
DURECT Corporation (DRRX)
Last durect corporation earnings: 3/3 04:05 pm
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Source: PR Newswire
CUPERTINO, Calif., Oct. 2, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). The meeting is tentatively scheduled for January 16, 2020. The FDA had previously assigned a user fee goal date of December 27, 2019; a new user fee goal date has not been assigned.DURECT commissioned the advisory services of Dr. Lee S. Simon to lead the Company's preparation efforts to prepare for the advisory committee meeting. Dr. Simon is a physician and research scientist who served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products from 2001 to 2003, and is now a Principal at SDG, LLC, an FDA advisory firm. "We look forward to a productive discussion with the advisory committe
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