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Organofluorides / Glucocorticoids / Butyrates / Corticosteroids / Difluprednate / Uveitis / Blindness / Bromfenac / Fluorometholone / Health / Chemistry / Medicine


N22-212S011 Difluprednate Clinical BPCA
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City

Reference / /

Company

Alcon / Durezol Corticosteroid Alcon Research Ltd. / Double-Masked / /

Country

United States / /

Event

FDA Phase / M&A / Product Issues / Product Recall / /

Facility

Laboratory Findings / /

IndustryTerm

ophthalmic solution / pediatric study protocol / bromfenac ophthalmic solution / parallel / tromethamine ophthalmic solution / sodium ophthalmic solution / /

MedicalCondition

photophobia / keratitis / corticosteroid-responsive inflammation / post-operative inflammation / superficial punctate keratitis / responsive inflammatory conditions / herpes zoster keratitis / acne rosacea / sympathetic ophthalmia / ocular itching / herpes / age undergoing cataract / posterior subcapsular cataract / seasonal allergic conjunctivitis / allergic conjunctivitis / pain / post-operative inflammation I / endogenous anterior uveitis / steroid-responsive inflammation / infective conjunctivitides / iritis / burns / temporal arteritis / Currently Available Post-Operative Inflammation / ocular inflammatory conditions / inflammation / corneal injury / cataract / uveitis / secondary ocular infection / /

MedicalTreatment

surgery / cataract surgery / radiation / /

Organization

Division of Scientific Investigations / PDUFA Goal Date Division / Advisory Committee / /

Person

Review Lucious Lim / Lucious Lim / /

Position

investigator / Currently Available Post-Operative / Major / /

Product

FML / Overdose / Pred Forte / Acular / Acular LS / Nevanac / Voltaren / Prednisolone acetate / Ophthalmic Suspension / diclofenac sodium / Triesence / dexamethasone sodium phosphate / ketorolac tromethamine / Kenalog / Maxidex / triamcinolone acetonide / Lotemax / Flarex / FML Forte / Xibrom / Vexol / C-10-004 / US / ST-601-007 / SE5-011 / /

PublishedMedium

the DSI review / /

Technology

radiation / pediatric study protocol / /

SocialTag