• FDA advisory committee hears Exparel data for supplemental new drug application

    6 monthes ago - By Healio

    The FDA Anesthetic and Analgesic Drug Products Advisory Committee began its review of the supplemental new drug application from Pacira Pharmaceuticals Inc., in which the company seeks expansion of the current Exparel (bupivacaine liposomal injectable suspension) label for infiltration to include its use as a nerve block to produce regional analgesia.
    The FDA approved bupivacaine liposomal injectable suspension in Oct. 2011 with the indication for administration into the surgical site to produce postsurgical analgesia and it is currently the only FDA-approved long-acting, non-opioid analgesic,
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  • FDA Advisory Committee Nixes Novel Pain Drug

    6 monthes ago - By Medscape

    Committee members expressed concern about insufficient study data on older patients and lack of clarity on plans for an abuse-deterrent program.
    Medscape Medical News
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