EUFLEXXA® - P010029/S008
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: EUFLEXXA®
Applicant: Ferring Pharmaceuticals, Inc.
Address: 4 Gatehall Drive, 3rd Floor, Parsippany, New Jersey USA 07054
Approval Date: October 11, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010029s008a.pdf
What is it? EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen.
How does it work? EUFLEXXA® is injected by a doctor into the space of the knee joint. This type of treatment is known as viscosupplementation,
When is it used? EUFLEXXA® is used to relieve pain in the knee due to osteoarthritis. It is used in patient who have not responded to treatments such as:
- physical therapy
- simple pain killers like acetaminophen
- non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen
What will it accomplish? EUFLEXXA® is designed to be given as three weekly injections. The effects of EUFLEXXA® originally lasted up to 12 weeks. New clinical data supports that the effects of EUFLEXXA® last up to 26 weeks after injection.
Side effects may include pain, back pain, muscle pain, and swelling in or around the knee.
When should it not be used? EUFLEXXA® should not be used on patients who have:
- A known allergy (hypersensitivity) to EUFLEXXA® or to sodium hyaluronate preperations.
- An infection or skin disease in the area of the injection site.
Additional information: Summary of Safety and Effectiveness and labeling are available online.