Pacira receives FDA approval of expanded label for Exparel
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Key takeaways:
- The expanded label includes administration as adductor canal block and sciatic nerve block in the popliteal fossa nerve block indications.
- Indication allows administration in more lower extremity procedures.
Pacira BioSciences announced FDA approval of its supplemental new drug application to expand the Exparel label to include administration in adults as an adductor canal block and as a sciatic nerve block in the popliteal fossa.
According to a company press release, the FDA approval comes after the Exparel (bupivacaine liposome injectable suspension) showed successful safety, efficacy and pharmacokinetics data vs. bupivacaine HCI in phase 3 trials.
“In line with our corporate mission to provide a non-opioid to as many patients as possible, this new indication provides additional flexibility in the use of Exparel as a regional analgesic for more than 3 million lower extremity procedures annually, further increasing the utility of Exparel for major orthopedic procedures,” David Stack, chairman and CEO of Pacira BioSciences, said in the release.
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