This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Orthovisc® High Molecular Weight Hyaluronan
Manufacturer: Anika Therapeutics, Inc.
Address: 236 West Cummings Park
Woburn, Massachusetts USA 01801
Approval Date: February 4, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030019a.pdf
What is it? ORTHOVISC® is a solution of sodium hyaluronate, a thick (viscous) substance that is naturally present in the knee joint. A doctor injects ORTHOVISC® into knee joints to relieve pain from osteoarthritis (OA) of the knee.
When is it used? ORTHOVISC® is used to treat pain from OA of the knee in patients who have not responded to non-drug treatments such as:
- physical therapy, and
- simple pain killers like acetaminophen.
What will it accomplish? Results of a clinical study indicate that patients who received injections of ORTHOVISC® experienced more pain relief from OA of the knee than patients who received salt water (placebo) injections.
When should it not be used? ORTHOVISC® should not be used in patients who have:
- a known allergy to hyaluronate preparations,
- a known allergy to birds or products derived from birds such as feathers, eggs and poultry, or
- infections or skin diseases in the area of the injection site or knee joint.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030019