DURECT Corporation announces FDA's acceptance of POSIDUR's NDA for post-operative pain relief
MENAFN - - 6/21/2013 5:36:32 AM
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DURECT Corporation announces FDA's acceptance of POSIDUR's NDA for post-operative pain relief
Jun 21, 2013 (Menafn - M2 EQUITYBITES via COMTEX) --Pharmaceutical company DURECT Corporation (nasdaqgm

RRX) stated on Thursday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for the investigational product POSIDUR.
According to the company, POSIDUR is a post-operative pain relief depot that utilises its patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery.
The company said its NDA of POSIDUR (SABER-Bupivacaine) is sufficiently complete to permit a substantive review.
In addition, the FDA has set 12 February 2014 as the Prescription Drug User Fee Act (PDUFA) goal date .
Concurrently, the company is in discussions with potential partners regarding licensing development and commercialisation rights to POSIDUR, for which it holds worldwide rights.
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