Zilretta Approved for Osteoarthritis
October 6, 2017 – The U.S. FDA has approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), manufactured by Flexion Therapeutics, for the treatment of knee osteoarthritis. The drug is a corticosteroid that can provide relief from pain caused by osteoarthritis, and must be administered into the affected joint by a specialist, such as an orthopedist, in a clinical setting. The drug is delivered via intra-articular injection. It is not approved for use in any joints other than the knee. One injection can provide relief for approximately three months.
The full launch of Zilretta is expected later this year. However, Flexion Therapeutics is expected to begin introducing the drug to market soon. Zilretta’s anticipated list price is approximately $570 per injection.
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.