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Ozurdex FDA Approval History

FDA Approved: Yes (First approved June 17, 2009)
Brand name: Ozurdex
Generic name: dexamethasone
Dosage form: Intravitreal Implant
Company: AbbVie Inc.
Treatment for: Macular Edema, Uveitis

Ozurdex (dexamethasone intravitreal implant) is a sustained-release, corticosteroid implant for the treatment of macular edema, non-infectious uveitis, and diabetic macular edema.

Development timeline for Ozurdex

DateArticle
Sep 29, 2014Approval FDA Approves Revised Indication for Ozurdex for the Treatment of Diabetic Macular Edema
Sep 25, 2010Approval Allergan Receives FDA Approval for Ozurdex as Treatment Option for Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Jun 18, 2009Approval Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease

Further information

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