Abuse-Deterrent Labeling Approved for Reformulated OxyContin

FDA also announced it will not approve generics to the original formulation of OxyContin.

The U.S. Food and Drug Administration has approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets that indicates the product has physical and chemical properties to make it more difficult to abuse, either by injection or snorting it.

"Additionally, because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin," the agency's announcement stated.

The original formulation was approved in December 1995, and FDA approved a reformulated version in April 2010. The announcement said Purdue Pharma stopped shipping original OxyContin to pharmacies in August 2010. "The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," said Dr. Douglas Throckmorton, deputy director for regulatory programs in FDA's Center for Drug Evaluation and Research. "While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin."

The reformulated product's tablet is harder to crush, break, or dissolve, and it also forms a viscous hydrogel and cannot be easily prepared for injection.

Download Center

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • Online Safety Training Buyer's Guide

    Use this handy buyer's guide to learn the basics of selecting online safety training and how to use it at your workplace.

  • COVID Return-to-Work Checklist, Fall 2021

    Use this checklist as an aid to help your organization return to work during the COVID-19 pandemic in a safe and healthy manner.

  • SDS Buyer's Guide

    Learn to make informed decisions while searching for SDS Management Software.

  • Risk Matrix Guide

    Risk matrices come in many different shapes and sizes. Understanding the components of a risk matrix will allow you and your organization to manage risk effectively.

  • Industry Safe

Featured Whitepapers

OH&S Digital Edition

  • OHS Magazine Digital Edition - October 2021

    October 2021

    Featuring:

    • TRAINING
      On Route To Safe Material Handling
    • SAFETY CULTURE
      Normalization of Deviations in Performance
    • IH:INDOOR AIR QUALITY
      Arresting Fugitive Dusts
    • PPE:FOOT PROTECTION
      Safety Shoes Make the Outfit for Well-Protected Workers
    View This Issue