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
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.
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