Shares of Parsippany, N.J.-based Pacira Pharmaceuticals fell more than 12 percent Tuesday after the company reported that the FDA will take three more months to review Exparel, its extended release local anesthetic, according to a Sign on San Diego report.
The FDA's decision moves the deadline for deciding whether Exparel can be sold from July 28 to Oct. 28. According to the report, the FDA decided to delay the review after agency officials requested more information about the drug and determined that the new information involved a "major amendment" to the new drug application.
Exparel combines the anesthetic bupivacaine and DepoFoam, a Pacira product developed to hold medicine inside microscopic chambers for extended release. Both of these products have been approved by the FDA.
Read the Sign on San Diego report on Exparel.
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The FDA's decision moves the deadline for deciding whether Exparel can be sold from July 28 to Oct. 28. According to the report, the FDA decided to delay the review after agency officials requested more information about the drug and determined that the new information involved a "major amendment" to the new drug application.
Exparel combines the anesthetic bupivacaine and DepoFoam, a Pacira product developed to hold medicine inside microscopic chambers for extended release. Both of these products have been approved by the FDA.
Read the Sign on San Diego report on Exparel.
Related Articles on Anesthesia:
Maquet Flow-i Anesthesia System Receives FDA Approval
Cleveland Clinic Anesthesiologist Resuscitates Newborn While on Duty as Cop
ASA Presents 6 Tactics to Relieve Drug Shortages