FzioMed Inc.'s PMA Application for Oxiplex Gel Accepted for Filing by FDA
10/4/2007 7:41:46 AM
SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--FzioMed, Inc. announced today that the U.S. Food and Drug Administration (FDA) has completed its initial review of the company’s Pre-Market Approval (PMA) application for Oxiplex spine surgery gel and has accepted the PMA for filing.
FDA also confirmed that the Oxiplex PMA will receive expedited processing. Oxiplex is intended to reduce pain and symptoms following lumbar spine surgery. FDA granted expedited review status because there are no approved alternative products in the U.S. for this debilitating condition.