Iluvien FDA Approval History
FDA Approved: Yes (First approved September 26, 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 timeline for Iluvien
| Date | Article |
|---|
| Sep 26, 2014 | Approval FDA Approves Iluvien for Diabetic Macular Edema |
| Apr 14, 2014 | Alimera Sciences Announces New PDUFA Date For Iluvien |
| Mar 27, 2014 | pSivida Announces Resubmission of New Drug Application for Iluvien |
| Oct 18, 2013 | Alimera Sciences Receives Complete Response Letter For Iluvien |
| Apr 2, 2013 | pSivida Reports on Resubmission to FDA of NDA for Iluvien for Chronic Diabetic Macular Edema |
| Mar 22, 2013 | pSivida Reports Updates on Iluvien for Planned Resubmission to FDA and European Launch |
| Aug 1, 2012 | pSivida Corp. Reports Alimera's Intention to Resubmit Application to FDA for Iluvien in DME Using Data from Completed Trials |
| Nov 11, 2011 | pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for Iluvien for DME |
| May 13, 2011 | pSivida Announces Resubmission of New Drug Application for Iluvien |
| Dec 26, 2010 | FDA Issues Complete Response Letter Regarding New Drug Application for Iluvien |
| Aug 31, 2010 | pSivida Announces Iluvien Receives FDA Priority Review for Treatment of Diabetic Macular Edema |
| Jun 29, 2010 | pSivida Announces Submission of NDA to FDA for an Ophthalmic Product for Diabetic Macular Edema |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
