Image result for Abuse-Deterrent Opioid Medications

WHAT: FDA Website on FDA standards for Abuse-Deterrent (AD) opioid formulations

WHY:  To help drug makers expedite regulatory path to market as quickly as possible. FDA is taking a flexible, adaptive approach to the evaluation and labeling of potentially AD products.

WHICH:  FDA has approved the following extended-release/long-acting (ER/LA) opioids with AD labeling 
  • OxyContin
  • Targiniq ER
  • Embeda
  • Hysingla ER
  • MorphaBond
  • Xtampza ER
  • Troxyca ER

NO immediate-release products with FDA-approved AD labeling c

LEARN

Published by Drug & Device Advisory Group


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