DURECT Corp. (DRRX) announced that its New Drug Application, or NDA, for the investigational product POSIDUR has been accepted by the U.S. FDA. The company said the PDUFA goal date, or the date the FDA expects to complete its review of the NDA, has been confirmed as February 12, 2014.
POSIDUR is a post-operative pain relief depot that utilizes DURECT's SABER technology, and is designed to provide up to three days of pain relief after surgery.
For comments and feedback: editorial@rttnews.com