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  1. Device Approvals, Denials and Clearances

SYNOJOYNT™ – P170016

SYNOJOYNT™ – P170016

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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: SYNOJOYNT™
PMA Applicant: Teva Pharmaceuticals USA, Inc.
Address:
Morris Corporate Center III
400 Interpace Parkway
Parsippany, NJ 07054
Approval Date: May 8, 2018
Approval Letter: Approval letter

What is it? SYNOJOYNT™ contains a single‐use syringe prefilled with a thick substance made of sodium hyaluronate in a salt water (saline) solution for injection in the osteoarthritic knee joint. This substance is similar to hyaluronic acid found in the knee joint space.

How does it work? SYNOJOYNT™ is injected by the physician directly into the intra-articular space inside the knee. The treatment consists of three weekly 3 mL doses.

When is it used? SYNOJOYNT™ is used for the treatment of pain in osteoarthritis of the knee in patients who have failed conservative noninvasive 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? SYNOJOYNT™ is intended to relieve pain associated with osteoarthritis in the knee for up to 6 months. In a clinical study with 396 patients, the 197 patients who received SYNOJOYNT™ had an average reduction in pain scores of 36 mm (on a 500 mm scale) greater than for the 199 patients receiving the saline control. In addition, the average percentage changes in stiffness scores were significantly better for patients receiving SYNOJOYNT™ (47.4% reduction in stiffness score) in comparison to those patients that received the saline control (35.8% reduction in stiffness score).

When should it not be used? SYNOJOYNT™ should not be used with:

  • patients who have a known hypersensitivity to hyaluronan preparations.
  • patients with infections or skin disease around the injection site.

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