Iluvien 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 History and FDA Approval Process for Iluvien
|Sep 26, 2014|| 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|
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