Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

Orthovisc® High Molecular Weight Hyaluronan - P030019

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:

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:

  • exercise,
  • 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:

Page Last Updated: 09/04/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English