| Document Date: 2012-09-11 15:54:35
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City Irvine / Reference / / Company Pearson / Allergan Inc. / / Country United States / / Event FDA Phase / / IndustryTerm chemical name / / MedicalCondition glaucoma / multiple abnormalities / non-infectious uveitis / macular edema / central retinal vein occlusion / fetal resorptions / cataracts / Headache / secondary ocular infections / Hypersensitivity OZURDEX / Carcinogenesis / Retinal Vein Occlusion OZURDEX / endophthalmitis / herpes / posterior subcapsular cataract / active epithelial herpes simplex keratitis / posterior subcapsular cataracts / dendritic keratitis / viral diseases / branch retinal vein occlusion / eye inflammation / Periocular Infections / cleft palate / inflammatory cytokines / Advanced Glaucoma / Eye pain / Periocular Infections OZURDEX / Posterior Segment Uveitis / Advanced Glaucoma OZURDEX / Retinal Vein Occlusion / ocular herpes / retinal detachments / Hypersensitivity / inflammatory cells / Ocular hypertension / Posterior Segment Uveitis OZURDEX / vaccinia / inflammation / corneal edema / Vitreous detachment / Cataract / varicella / mycobacterial infections / fungal diseases / secondary ocular infection / / MedicalTreatment drug delivery system / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position optic nerve head / General / / Product Intravitreal Injection / dexamethasone / WARNINGS AND PRECAUTIONS Intravitreal injections / dexamethasone sodium phosphate / Intravitreal Injection-related Effects Intravitreal injections / Posterior Lens Capsule / S-007 / / ProvinceOrState California / / Technology Pharmacokinetics / drug delivery system / / URL www.fda.gov/medwatch / /
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NDA[removed]S-007 Page 3 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OZURDEX® safely and effectively. See full prescribing information