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Biotech Stocks Facing FDA Decision In November 2023

Pacira BioSciences
Pacira BioSciences

Pacira BioSciences Inc. (PCRX) is seeking FDA approval to expand the use of Exparel label to include both single-dose sciatic nerve block in the popliteal fossa as well as femoral nerve block in the adductor canal to produce regional analgesia in lower extremity procedures.

The decision on the proposed expanded use is expected on November 13, 2023.

Exparel is currently indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

According to the company, an approval in the proposed expanded use would give clinicians a safe and effective tool to provide four days of postsurgical pain control, reduce opioid requirements, and continue to migrate relevant orthopedic procedures to the outpatient setting.

The net product sales of Exparel were $265.5 million in the first half of this year, slightly down from $266 million in the year-ago period.

PCRX closed Friday’s trading at $27.57, up 1.03%.