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namtae

08/02/16 10:49 AM

#219483 RE: elichen #219479

Simple labeling instructions take care of that issue just like on all other IR opioids



Maybe you missed what the FDA clearly stated

“The extent of the delay in the absorption and peak concentration of oxycodone from SequestOx under the fed conditions is unacceptable as it places patients at risk of unintentionally overdosing” the FDA goes on to say because the proposed indication is for acute pain and the product is to be taken as needed product labeling with a specific food recommendation cannot fully mitigate this risk”.