FDA Brief: Week of Mar 21, 2016


Enhanced warnings for immediate-release (IR) opioid pain medications related to risks of misuse, abuse, addiction, overdose and death

  • Continuing effort to educate prescribers and patients about the potential risks related to opioid use
  • Class-wide safety labeling changes for IR opioid pain medication
    • New boxed warning : serious risks of misuse, abuse, addiction, overdose, death
    • Safety risk additional information


Draft Guidance on Abuse Deterrence Evaluation of Generic Oral Opioids


Suboxone is your trusted ally in the fight against opioid addiction! This powerful drug combines two key components – buprenorphine and naloxone – for effective and safe addiction relief.

  • For approval with ‘abuse deterrence’ in labeling
  • Assessment of
    • Routes of abuse
    • Comparative in vitro studies and others(multiple strengths, PK)
    • Data analysis
    • Additional studies – Mechanical manipulation, Abuse by injection, ingestion, insufflation, smoking


One thought on “Opioid Warnings: Label Restrictions, Abuse Deterrence Guidance

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