Pharmaceutical Approval Update

摘要

Hydrocodone Bitartrate (Vantrela ER): Manufacturer: Teva Pharmaceuticals, Inc., North Wales, Pennsylvania. Date of Approval: January 17, 2017. Indication: Vantrela ER is an opioid agonist used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release (ER) opioid formulations, Vantrela ER should be reserved for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. This medication is not indicated as an as-needed analgesic.