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Pacira's Exparel Faces Efficacy Questions On Nerve Block Indication

 
• By Sue Sutter

US FDA advisory committee to weigh whether efficacy data support an expanded label for the local anesthetic; despite Pacira's completion of two new studies following a complete response letter, FDA continues to harbor concerns about adequacy of the data to support a broad nerve block claim.

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Efficacy questions are expected to dominate when a US FDA advisory committee convenes Feb. 14 to consider whether labeling for Pacira Pharmaceuticals Inc.'s Exparel (bupivacaine) should be expanded to include use as a nerve block and, if so, the specificity of any new claim for the local anesthetic.

At a Feb. 14 meeting, the Anesthetic and Analgesic Drug Products Advisory Committee will discuss Pacira's supplemental new drug application...

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