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Pacira's Exparel: US FDA Panel Narrowly Rejects Nerve Block Claim

 
• By Sue Sutter

Inconsistent efficacy data and safety concerns about falls and systemic toxicity lead to advisory committee vote against a labeling expansion for the local anesthetic; Pacira's proposed revisions to the drug's existing infiltration claim also meet some resistance.

FDA entrance sign 2016

Citing efficacy as well as safety concerns, a US FDA advisory committee narrowly recommended against the addition of a nerve block indication to the labeling ofPacira Pharmaceuticals Inc.'s local anesthetic Exparel (bupivacaine liposome injectable suspension).

At a Feb. 15 meeting, the Anesthetic and Analgesic Drug Products Advisory Committee voted 6-4 that the data submitted do...

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