Durect (DRRX)

[BooDog]

SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss new drug application (NDA) 204803, bupivacaine
extended-release solution for instillation, submitted by DURECT Corp., for the proposed
indication of post-surgical analgesia. The committee will discuss whether the Applicant
adequately demonstrated the safety and efficacy of bupivacaine extended-release solution for
post-surgical analgesia and the appropriateness of the proposed patient populations. The
committee will also be asked to discuss the approvability of this product.
FDA intends to make background material available to the public no later than 2 business
days before the meeting. If FDA is unable to post the background material on its website prior to
the meeting, the background material will be made publicly available at the location of the
advisory committee meeting, and the background material will be posted on FDA’s website after
the meeting. Background material is available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate
advisory committee meeting link.


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AdCom Jan 16th for bupivacaine extended-release solution for instillation, submitted for the proposed indication of post-surgical analgesia

https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-25278.pdf