Teva announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) recommended the approval of Vantrela ER (hydrocodone bitartrate extended-release) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The Committees voted 14-3 that Vantrela ER should be labeled as an abuse-deterrent product by the oral and nasal routes of abuse and voted 16-1 that Vantrela ER should be labeled as an abuse-deterrent product by the intravenous route of abuse. The Company anticipates that the label for Vantrela ER, if approved, will describe abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated.
The FDA will consider the Committees’ guidance during the review of the New Drug Application (NDA) of Vantrela ER.
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