FDA Okays Purdue's Newer OxyContin; Payors And Physicians Chew On Drug's Benefit
This article was originally published in The Pink Sheet Daily
Purdue's reformulated OxyContin could face generics in 2013 unless FDA withdraws the initial NDA because of safety concerns.
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Physician group appeals for FDA to rescind approval for moderate non-cancer pain and Massachusetts Democrat Rep. William Keating introduces legislation that would bar FDA approval of a non-tamper-resistant opioid drug if the same active moiety already was approved in a tamper-resistant product.
New England Journal of Medicine report notes an increase in heroin use among patients with opioid dependence following the introduction of reformulated OxyContin; Purdue post-marketing study also finds an increase in heroin-related calls to poison control centers.