FDA approves Exparel anesthetic for children: 4 details


The Food and Drug Administration approved Pacira's supplemental new drug application to expand the use of its long-acting local anesthetic, Exparel, in children.


Four details:

1. Pacira's bupivacaine liposome injectable suspension product is used in a variety of procedures, including orthopedic and spine surgeries.

2. The FDA approved Exparel for adults in 2011 and now will allow surgeons to use the product for pediatric patients ages 6 years and older.

3. Exparel is the first long-acting local anesthetic approved for pediatric use. The approval is based on a phase 3 study of Exparel in pediatric patients undergoing spine and cardiac procedures, which found no safety concerns.

4. More than 8 million patients have received Exparel for nonopioid pain control.

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