Third Time's Not The Charm For Opioid Painkiller At FDA

Law360, New York (September 26, 2016, 5:19 PM EDT) -- Two companies that landed in hot water with the U.S. Food and Drug Administration earlier this month, for allegedly making statements about the safety and effectiveness of their opioid painkiller Remoxy ER before its approval, said Monday that the agency once again rejected their drug.

The FDA sent Durect Corp. and Pain Therapeutics Inc. a response letter about their resubmitted Remoxy ER new drug application, stating the oxycodone capsule cannot be approved in its current form, according to the companies. This marks the third time the agency has rejected the drug, which is intended to lower addiction risks because it cannot...

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