Drug news
Pacira Pharma submits sNDA to FDA for Exparel as nerve block-Pacira Pharma
Pacira Pharmaceuticals has announced the submission of a supplemental New Drug Application (sNDA) to the FDA for a nerve block indication for Exparel (bupivacaine liposome injectable suspension). The sNDA is based on positive data from a Phase III study assessing the safety and efficacy of Exparel in femoral nerve block for total knee Arthroplasty, and will also include additional safety data from a Phase III study of Exparel used to perform an intercostal nerve block for thoracotomy. A PDUFA target date of March 5, 2015 is expected.