FDA Expands Indications for Ozurdex
September 26, 2014 – The US Food and Drug Administration (FDA) expanded the indication for Ozurdex (dexamethasone intravitreal implant) 0.7mg. Ozurdex, manufactured by Allergan, was originally approved for use only for Diabetic Macular Edema (DME) in adults who also have artificial lens implants or who are planning to have cataract surgery. The expanded indications now include macular edema following branch retinal vein occlusion (BRVO) and central vein occlusion (CRVO) and for the treatment of non-infectious uveitis (inflammation of the middle layer of the eye).
If you have any questions you can contact our Call Center at 1-877-723-6005.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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. Prices referenced are estimates based on available data and are subject to change at the time a claim is processed. 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.