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DURECT announced the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met to discuss the Class 2 New Drug Application (NDA) resubmission for POSIMIR® (bupivacaine extended-release solution).
Durect has signed a development and commercialisation agreement with Sandoz, a division of Novartis, to develop and market Posimir (Saber-Bupivacaine) in the US.