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Iluvien Approval History

  • FDA approved: Yes (First approved September 26th, 2014)
  • Brand name: Iluvien
  • Generic name: fluocinolone acetonide
  • Dosage form: Intravitreal Implant
  • Company: pSivida Corp.
  • Treatment for: Macular Edema

Iluvien (fluocinolone acetonide) is an intravitreal implant for the treatment of diabetic macular edema.

Development History and FDA Approval Process for Iluvien

Sep 26, 2014Approval FDA Approves Iluvien for Diabetic Macular Edema
Apr 14, 2014Alimera Sciences Announces New PDUFA Date For Iluvien
Mar 27, 2014pSivida Announces Resubmission of New Drug Application for Iluvien
Oct 18, 2013Alimera Sciences Receives Complete Response Letter For Iluvien
Apr  2, 2013pSivida Reports on Resubmission to FDA of NDA for Iluvien for Chronic Diabetic Macular Edema
Mar 22, 2013pSivida Reports Updates on Iluvien for Planned Resubmission to FDA and European Launch
Aug  1, 2012pSivida Corp. Reports Alimera's Intention to Resubmit Application to FDA for Iluvien in DME Using Data from Completed Trials
Nov 11, 2011pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for Iluvien for DME
May 13, 2011pSivida Announces Resubmission of New Drug Application for Iluvien
Dec 26, 2010FDA Issues Complete Response Letter Regarding New Drug Application for Iluvien
Aug 31, 2010pSivida Announces Iluvien Receives FDA Priority Review for Treatment of Diabetic Macular Edema
Jun 29, 2010pSivida Announces Submission of NDA to FDA for an Ophthalmic Product for Diabetic Macular Edema

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