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NDA 19-404/S-026 Page 3 ® OCUFEN (flurbiprofen sodium ophthalmic solution, USP) 0.03% sterile DESCRIPTION OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use. Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenylyl) propionate dihydrate. Structural Formula: C H FNaO •2H O Mol. Wt. 302.27 15 12 2 2 Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium ® hydroxide to adjust pH. The pH of OCUFEN ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg. CLINICAL PHARMACOLOGY Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a