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Vantrela ER Approval History

Medically reviewed on 18 January, 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

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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