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Vantrela ER Approval History

Reviewed on Jan 18, 2017 by J.Stewart BPharm.

  • FDA approved: Yes (First approved January 17th, 2017)
  • Brand name: Vantrela ER
  • Generic name: hydrocodone bitartrate
  • Dosage form: Extended-Release Tablets
  • Company: Teva Pharmaceuticals USA, Inc.
  • Treatment for: Pain

Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Vantrela ER is formulated with physicochemical properties intended to make the tablets more difficult to manipulate for misuse and abuse, including resistance to crushing, breaking, dissolution, and the formation of a viscous substance intended to make injection difficult. However, abuse by the oral, intranasal and intravenous routes is still possible.

Vantrela ER tablets are taken orally at the prescribed dose, every 12 hours. Tablets must be swallowed whole and must not be crushed or chewed, dissolved, snorted or injected due to the rapid release and absorption of a potentially fatal dose of hydrocodone. Vantrela ER comes with a Boxed Warning that advises the risks of addiction, abuse, and misuse, which can lead to overdose and death, as well as serious, life-threatening, or fatal respiratory depression.

Common side effects include nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.

Development History and FDA Approval Process for Vantrela ER

Jan 18, 2017Approval Teva Receives FDA Approval for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets Formulated with Proprietary Abuse Deterrence Technology
Jun  7, 2016Teva Gains Recommendation for Approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

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