Durolane Injection Approved for Knee Osteoarthritis
August 29, 2017 – The U.S. FDA has approved Durolane® (hyaluronic acid, intra-articular), manufactured by Bioventus, for the treatment of pain caused by osteoarthritis of the knees. It works by helping to replace the natural fluids that provide lubrication and protection in the joint. Durolane must be administered by a healthcare professional, and is delivered by injection directly into the affected joint. Patients treated with Durolane can experience up to six months of pain relief following the injection. Durolane was first approved sixteen years ago in Europe, and has since been approved in multiple countries, including Mexico and Canada. Its U.S. launch is expected early next year.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.