🇺🇸 IlUVIEN in United States

FDA authorised IlUVIEN on 26 September 2014 · 764 US adverse-event reports

Marketing authorisations

FDA — authorised 26 September 2014

  • Application: NDA201923
  • Marketing authorisation holder: ALIMERA SCIENCES INC
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Intraocular Pressure Increased — 170 reports (22.25%)
  2. Device Failure — 109 reports (14.27%)
  3. Circumstance Or Information Capable Of Leading To Medication Error — 87 reports (11.39%)
  4. Device Dislocation — 78 reports (10.21%)
  5. Medical Device Removal — 74 reports (9.69%)
  6. Off Label Use — 62 reports (8.12%)
  7. Product Administration Error — 52 reports (6.81%)
  8. Vitrectomy — 50 reports (6.54%)
  9. Glaucoma — 41 reports (5.37%)
  10. Visual Impairment — 41 reports (5.37%)

Source database →

IlUVIEN in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is IlUVIEN approved in United States?

Yes. FDA authorised it on 26 September 2014; FDA has authorised it.

Who is the marketing authorisation holder for IlUVIEN in United States?

ALIMERA SCIENCES INC holds the US marketing authorisation.