BIOMATRIX SYNVISC HA INJECTION APPROVABLE FOR OSTEOARTHRITIS KNEE PAIN; FIRM PURSUING INDICATION FOR USE PRIOR TO NSAIDs IN DISCUSSIONS WITH FDA
This article was originally published in The Gray Sheet
Executive Summary
Biomatrix is pursuing approval of Synvisc hyaluronic acid-based product with an indication for use prior to non-steroidal anti-inflammatory drugs (NSAIDs) despite a recommendation by FDA's Orthopedic and Rehabilitation Devices Panel for a more stringent indication. In a 7-2 vote, the panel said FDA should approve Synvisc for "use in patients with osteoarthritis" of the knee "who are resistant to treatments with analgesics and non-steroidal anti-inflammatory" drugs.