GLIATECH ADCON-L ANTI-ADHESION GEL APPROVABLE FOR REDUCING PERIDURAL FIBROSIS AFTER LUMBAR SURGERY, FDA PANEL SAYS; DATA DO NOT SUPPORT PAIN RELIEF CLAIM
This article was originally published in The Gray Sheet
Executive Summary
Gliatech's Adcon-L anti-adhesion gel should include in final labeling a statement explaining that no data exist to support long-term pain relief, FDA's Orthopedic and Rehabilitation Devices Advisory Panel recommended at a Dec. 12 meeting. The suggestion was one of several conditions for FDA approval of a premarket approval application for Adcon-L in reducing peridural fibrosis and adhesions following single-level (L4-L5 or L5-S1), posterior lumbar laminectomy or discectomy.