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  • Regulatory NewsRegulatory News

    Endo Pulls Opioid From US Market at FDA's Request

    Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request to remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market. FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after "a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.” As a res...
  • Regulatory NewsRegulatory News

    FDA Calls to Remove Endo Opioid From US Market

    The US Food and Drug Administration on Thursday requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market due to public health concerns over abuse. "After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," FDA said . The move to call on a company to remove a drug for reasons of safety or effe...
  • Regulatory NewsRegulatory News

    Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids

    A group of nearly two dozen Democratic legislators is calling on the US Food and Drug Administration (FDA) to label immediate-release opioids with more serious warnings meant to reflect "the serious risks of abuse" associated with the drug. In a letter sent on 4 June 2015 to FDA Acting Commissioner Stephen Ostroff, the legislators said their concerns are driven by "the national public health crisis of prescription drug overdoses." Opioid-related overdoses and deaths have...
  • FDA Looks for Stakeholder Input on Trials Meant to Assess Abuse of Opioids

    The US Food and Drug Administration (FDA) has experienced no shortage of criticism in recent years about its regulation of opioid-based painkillers in light of the drugs' contribution to what the Centers for Disease Control and Prevention (CDC) calls an " epidemic of prescription painkiller abuse ." But while FDA's fault (or lack thereof) is a matter of intense debate, the agency has nevertheless been taking steps in recent years meant to reduce abuse while maintaining a...
  • Asking for More Time, FDA Denies Citizen Petition Asking for All Opioids to Be Crush-Resistant

    The US Food and Drug Administration (FDA) has denied a petition submitted by Endo Pharmaceuticals that sought to require manufacturers seeking to market generic versions of its Opana ER (oxymorphone hydrochloride) product to show evidence of similar crush-resistant qualities, saying it needs more time to determine appropriate testing standards-a potential indication that it may be leaning toward such requirements in the future. Background Endo's drug had received appr...
  • Drug Reformulations Lead to Shifting Patterns of Abuse

    A report in the New England Journal of Medicine (NEJM) found abuse of a OxyContin, a branded version of the opioid oxycodone, went down significantly between 2010 and the first quarter of 2012 as the result of a new time-release formulation released in August 2010 by Purdue Pharma. The reformulation made it more difficult to turn the medicine into a powder, thereby reducing an abuser's ability to snort or inject the medication. The article, by Theodore Cicero, PhD, of ...