| Document Date: 2011-10-20 14:37:56
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City Dimas / Reference / / Company Gilead Sciences Inc / Becton Dickinson & CO / AMD / Eyetech Inc. / Palm Beach / / Currency pence / / Event FDA Phase / / IndustryTerm preservativefree solution / aqueous solution / in vivo assay systems / assay systems / chemical name / mg/mL solution / / MedicalCondition chest pain / headache / urinary retention / arthritis / retinal detachment / sterility / punctate keratitis / bronchitis / urinary tract infection / Endophthalmitis / macular degeneration / cerebrovascular accident / nausea / anaphylaxis / vitreous hemorrhage / transient ischemic attack / conjunctivitis / periocular infections / age-related macular degeneration / Hypersensitivity / diarrhea / corneal edema / photopsia / vitreous disorder / blindness / hypertension / corneal epithelium disorder / Carcinogenesis / vertigo / iatrogenic traumatic cataract / eye irritation / Experience Anaphylaxis / mydriasis / allergic conjunctivitis / vomiting / eye inflammation / diabetes mellitus / anterior chamber inflammation / pleural effusion / angioedema / eye pain / infection / contact dermatitis / retinal edema / dizziness / inflammation / eyelid irritation / bone spur / cataract / blepharitis / / MedicalTreatment sham treatment / photodynamic therapy / / Organization Macugen administration / DOSAGE AND ADMINISTRATION / FDA / / / Position optic nerve head / General / / Product Intravitreal Injection / sodium chloride / polyethylene glycol / MACUGEN / OPHTHALMIC INTRAVITREAL INJECTION / Endophthalmitis Intravitreous injections / FOR OPHTHALMIC INTRAVITREAL INJECTION / Administration The injection / S-018 / / ProvinceOrState New Jersey / Florida / California / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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NDA[removed]S-018 Page 3 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all of the information needed to use MACUGEN® safely and effectively. See full