FDA accepts NDA for Remoxy for moderate to severe chronic pain
DURECT Corporation announced that its New Drug Application (NDA) for Remoxy was accepted by the FDA for the treatment of moderate to severe chronic pain. This resubmitted NDA has a projected PDUFA goal date of June 23, 2011.
Remoxy is a controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use.
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