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, 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|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.