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: TRILURON™
PMA Applicant: Fidia Farmaceutici S.p.A.
Address:  (manufactured for) Fidia Pharma USA Inc., 100 Campus Drive, Suite 105, Florham Park, New Jersey 07410
Approval Date: March 26, 2019
Approval Letter: Approval Order

What is it? TRILURON™ is a single-use syringe prefilled with sodium hyaluronate. Hyaluronate is a chemical found in the body, and it is present in joint tissues and in the fluid that fills the joints. The body's own hyaluronate acts like a lubricant and a shock absorber in the joint, and it is needed for the joint to work properly. In osteoarthritis, there may not be enough hyaluronate, and there may be a change in the quality of the hyaluronate and its cushioning and lubricating abilities.

How does it work? TRILURON™ is injected by a doctor directly into the patient's knee and provides relief of pain associated with osteoarthritis for up to six months. The treatment consists of three weekly doses of 2 mL of TRILURON™.

When is it used? TRILURON™ is used for the treatment of pain in osteoarthritis of the knee in patients who have not responded to non-surgical treatments from physical therapy and simple pain medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.

What will it accomplish? TRILURON™ is intended to relieve pain associated with osteoarthritis in the knee for up to six months after the first injection.

When should it not be used? TRILURON™ should not be used on patients with:         

• Known hypersensitivity (allergy) to sodium hyaluronate preparations.
• Past and present infections or skin diseases around the injection site.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness (SSED)
• Patient Labeling: Patient Information
• Physician Labeling: TRILURON™ (Sodium Hyaluronate)
• PMA Database Entry