Nuflexxa™ (1 percent Sodium Hyaluronate) - P010029

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Nuflexxa™ (1% Sodium Hyaluronate)
Manufacturer:  Savient Pharmaceuticals, Inc.
Address:  One Tower Center Boulevard, East Brunswick , New Jersey USA 08816
Approval Date:  December 3, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010029a.pdf

What is it?   Nuflexxa™ is a solution of sodium hyaluronate, a thick (viscous) substance that is naturally present in the knee joint. A doctor injects Nuflexxa™ into knee joints to relieve pain from osteoarthritis of the knee.

When is it used? Nuflexxa™ is used to treat pain from osteoarthritis (OA) of the knee in patients who have not responded to non-drug treatments such as

• exercise
• physical therapy
• simple pain killers like acetaminophen

What will it accomplish? Results of a clinical study indicate that patients who received injections of Nuflexxa™ experienced pain relief from OA which was no worse than that of another approved sodium hyaluronate.

When should it not be used? Nuflexxa™ should not be used in patients who have

• a known allergy (hypersensitivity) to hyaluronate preparations
• infections or skin diseases in the area of the injection site or joint

Additional information: The SSED and Labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010029