MONOVISC™ - P090031
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: MONOVISC™
PMA Applicant: Anika Therapeutics, Inc.
Address: 32 Wiggins Avenue, Bedford, MA, 01730
Approval Date: February 25, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031a.pdf
What is it? MONOVISC™ is a single injection supplement to the synovial fluid of the osteoarthritic joint. It is intended for the treatment of pain and improves joint mobility in patients suffering from osteoarthritis (OA) of the knee.
The Monovisc device is comprised of hyaluronic acid (HA) which is derived from a non-animal source. This viscosupplementation procedure is intended to treat pain in patients with moderate osteoarthritis of the knee who have failed to respond to conservative care (non‐pharmacological therapy) such as physical therapy and simple pain relievers (analgesics).
How does it work? Monovisc is a single injection into the knee. It functions as a physical lubricant for the treatment of pain in patients with moderate osteoarthritis of the knee who have failed conservative non‐pharmacological therapy and simple analgesics.
When is it used? Monovisc is intended for the treatment of pain in patients with moderate osteoarthritis of the knee who have failed conservative non-pharmacological therapy and simple analgesics.
What will it accomplish? After the study was completed, Monovisc (a single injection of HA) was compared to the approved Orthovisc (P030019 -- three injections of HA) data collected from clinical trials conducted in the U.S. Further analysis showed that MONOVISC was not inferior to Orthovisc in providing pain relief to patients who had not been able to find pain relief with simple pain medication or exercise.
When should it not be used?
- Do not administer to patients with a known allergy (hypersensitivity) to hyaluronate preparations.
- Do not administer to patients with a known hypersensitivity to gram positive bacterial proteins.
- Do not inject MONOVISC in the knees of patients with infections or skin diseases in the area of the injection site or joint.
- Do not administer to patients with known bleeding disorders.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.