FIDIA'S HYALGAN PMA FOR OSTEOARTHRITIS PAIN RECOMMENDED FOR APPROVAL BY FDA ADVISORY PANEL; USE AFTER FAILED CONSERVATIVE THERAPY ENDORSED
This article was originally published in The Gray Sheet
Executive Summary
Fidia Pharmaceutical's Hyalgan premarket approval application received a unanimous recommendation for approval with conditions for treating pain caused by osteoarthritis of the knee from FDA's Orthopedic and Rehabilitation Devices Panel Nov. 21 in Gaithersburg, Maryland. The panel conditioned its approval recommendation on five labeling changes.