DURECT Provides REMOXY® Update Freitag, 01.07.2016 15:10 von PR Newswire
PR Newswire
CUPERTINO, Calif., July 1, 2016
CUPERTINO, Calif., July 1, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has announced that the U.S. Food and Drug Administration (FDA) has determined that an Advisory Committee meeting for REMOXY®, which had been tentatively scheduled for August 5, 2016, is unnecessary and will not be held. REMOXY was previously the subject of an Advisory Committee meeting in 2008. Pain Therapeutics also stated that the FDA advised them that the regulatory review of the REMOXY New Drug Application (NDA) remains active and on-going. The Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA of September 25, 2016 is unchanged. http://www.ariva.de/news/durect-provides-remoxy-update-5800299 |