Synvisc-One (hylan GF-20) - P940015/S012
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: Synvisc-One™ (hylan GF-20)
PMA Applicant: Genzyme Biosurgery
Address: Genzyme Corporation, 55 Cambridge Parkway, Cambridge, MA 02142
Approval Date: February 26, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P940015S012a.pdf
What is it? Synvisc-One™ (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan polymers (derivatives of hyaluronan or sodium hyaluronate) produced from chicken combs. Synvisc-One is a single 6 mL injection treatment regimen. The total treatment volume is identical between the currently marketed Synvisc (3 injection regimen, approved under P040015) and the Synvisc-One product.
How does it work? Synvisc-One is a viscosupplementation device, which is injected directly into the intra-articular space inside the knee.
When is it used? Synvisc-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
What will it accomplish? Synvisc-One is designed as a single intra-articular injection option to reduce pain associated with osteoarthritis of the knee for up to 26 weeks. Side effects may include pain in the knee at the injection site, stiffness, swelling or warmth in or around the knee, changes in the way that you walk (e.g., limping).
When should it not be used? Synvisc-One should not be used in the following situations:
- Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.
- Do not inject Synvisc-One in the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site.
Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.