UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`AKORN, INC.
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`Petitioner
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`v.
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`SENJU PHARMACEUTICAL CO., LTD.
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`MITSUBISHI CHEMICAL CORPORATION
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`Patent Owner
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`Case IPR2015-01205
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`Patent 6,114,319
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`DECLARATION OF DIANE PANG REGARDING AUTHENTICATION OF
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`FML FORTE® (FLUOROMETHOLONE OPHTHALMIC SUSPENSION)
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`0.25% LABEL
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`SENJU-MITSUBISHI 2092
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`IPR2015-01205
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`U.S. Patent No. 6,114,319
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`Declaration of Diane Pang
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`Exhibits Referenced In This Declaration
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`Printout of “fml forte” search results from
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`“Drus v FDA” database
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`Label for fml forte® (fluorometholone ophthalmic
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`susension 0.25%
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`T A
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`IPR2015-01205
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`U.S. Patent No. 6,114,319
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`Declaration of Diane Pang
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`1, Diane Pang, am an attorney at O’Me1veny & Myers LLP.
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`Exhibit A is a true and correct copy of the search results for “fm1
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`forte” that I obtained from the “Drugs@FDA” database on June 22, 2016.
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`3.
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`Exhibit B is a true and correct copy of the fm1forte®
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`(fluorometholone ophthalmic suspension) 0.25% Label that I obtained from the
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`“Drugs@FDA” database on June 22, 2016.
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`4.
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`I declare under penalty of perjury under the laws of the United States
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`that the foregoing is true and correct. This declaration is executed this 22"‘! day of
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`June, 2016, at Newmrt Beach, California.
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`91144.2. K Pagg
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`Exhibit A
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`Dn1gs@FD/\: l-‘DA Approved Drug Products
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`H-‘. in. l‘. H i mm - -.
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`U.S. Food and Drug Administration
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`Pir_.:.:».:t_ar‘i-3 and Sign‘.-:it_i~1-3 Yijauv llealich
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`A to Z Index
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`Medical Devices
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`Fladiation-Emitting Products Veccinea. Blood 8- Biologic:
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`Anlmalaiveterinary Cosmetics
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`Tobacco Products
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`0 FDA Home 0 Drug Databases 0 Drugs@FDA
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`DIega@lDI
`FDA Approved Drug Products
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`FAQ | Instructions | Glossary | Contact Us
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`II-'J_.
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`Q Email Link
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`Back to Search Results
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`Drug Details
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`Drug Nameia)
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`FDA Application No.
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`FML FORTE
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`(NDA) 019216
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`FLUOROHETHOLON E
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`ALLERGAN
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`Apr" 23. 1986
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`3 New croueelorm
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`5 Standard review drug
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`I There are no Therapeutic Equlvelenta
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`0 Approval Hlatory. Letters. Hevlewa. and Related Documents
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`0 Label lnfonnalion
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`Products on Application (HDA) #019216
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`Click on a column header to re-aort the table:
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`Active lngradlenta
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`DoaageFormll-Iouta
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`FML FOFlTE
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`FLUOROMETHOLONE W SUSF-‘ENSl0N!DFl0PS:0PHTHALM|C
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`Iurkatlng
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`Statue
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`Prescription
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`Back to Top | Back to Previous Page | Back to Drugs@FDA Home
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`sumy
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`htrp:Irwww.aoccssdara.fdagovrscriprsrcder/drugsari'daJindcx.cfm'?fusaaction:Scarch.DrugDe1ails[6f22.QlJ [6 11:49:47 AM]
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`Dtugs@l-‘DA: FDA Approved Drug Products
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`Tim. .3. D [3 I ‘mi
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`E,....,.,..,,..,.,,.,.......
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`lnumntlond Programs
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`Training Ind continuing Education
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`hl1p:ifwww.|ocessdu|.fda.gov!scripIsIcd:ri'd:ugsatfdm'indeii.cfm?fiiscaclion=Search.DrugDciui|s[6i22.v'2.016 11:49:47 AM]
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`Exhibit B
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`NDA 19-216/S-025
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`Page 3
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`FML FORTE®
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`(lluorometholone ophthalmic suspension, USP) 0.25%
`sterile
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`DESCRIPTION
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`FML FORTE® (fluorometholone ophthalmic suspension, USP) 0.25% is a sterile, topical anti-
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`inflammatory agent for ophthalmic use.
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`Chemical Name
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`Fluorometholone: 9-Fluoro-11B, 17-dihydroxy-6o¢-methylpregna-1,4-diene-3,20-dione.
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`Structural Formula
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`Contains
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`Active: fluorometholone 0.25%. Preservative: benzalkonium chloride 0.005%. Inactives:
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`edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride;
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`sodium phoséahate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH.
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`FML Forte suspension is formulated with a pH from 6.2 to 7.5.
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`CLINICAL PHARMACOLOGY
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`Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably
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`delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte
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`migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar
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`There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.
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`However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory
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`proteins, collectively called lipocortins. It is postulated that these proteins control the
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`biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by
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`inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released
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`Reference ID: 3258817
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`NDA 19-216/S-025
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`Page 4
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`Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of
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`documented steroid-responders, fluorometholone demonstrated a significantly longer average
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`time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small
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`percentage of individuals, a significant rise in intraocular pressure occurred within one week.
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`The ultimate magnitude of the rise was equivalent for both drugs.
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`INDICATIONS AND USAGE
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`FML FORTE® suspension is indicated for the treatment of corticosteroid-responsive
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`inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
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`CONTRAINDICATIONS
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`FML FORTE® suspension is contraindicated in most viral diseases of the cornea and
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`conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaocinia, and
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`varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
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`FML FORTE® suspension is also contraindicated in individuals with known or suspected
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`hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
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`WARNINGS
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`Prolonged use of corticosteroids may increase intraocular pressure in susceptible individuals,
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`resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of
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`vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host
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`immune response and thus increase the hazard of secondary ocular infections.
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`Various ocular diseases and long-term use of topical corticosteroids have been known to cause
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`corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or
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`scleral tissue may lead to perforation.
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`Acute purulent infections of the eye may be masked or activity enhanced by the presence of
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`If this product is used for 10 days or longer, intraocular pressure should be routinely monitored
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`even though it may be difficult in children and uncooperative patients. Steroids should be used
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`with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
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`The use of steroids after cataract surgery may delay healing and increase the incidence of bleb
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`Use of ocular steroids may prolong the course and may exacerbate the severity of many viral
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`infections of the eye (including herpes simplex). Employment of a corticosteroid medication in
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`the treatment of patients with a history of herpes simplex requires great caution; frequent slit
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`lamp microscopy is recommended.
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`Reference ID: 3258817
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`NDA 19-216/S-025
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`Page 5
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`PRECAUTIONS
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`General
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`The initial prescription and renewal of the medication order beyond 20 milliliters of FML
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`FORTE® suspension should be made by a physician only after examination of the patient with
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`the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein
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`staining. If signs and symptoms fail to improve after two days, the patient should be re-
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`As fungal infections of the cornea are particularly prone to develop coincidentally with long-
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`term local corticosteroid applications, fungal invasion should be suspected in any persistent
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`corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be
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`taken when appropriate.
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`If this product is used for 10 days or longer, intraocular pressure should be monitored (see
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`WARNINGS).
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`Information for Patients
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`If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should
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`be advised to discontinue use of the medication and consult a physician.
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`This product is sterile when packaged. To prevent contamination, care should be taken to avoid
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`touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one
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`person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of
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`The preservative in FML FORTEE suspension, benzalkonium chloride, may be absorbed by soft
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`contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15
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`minutes after instilling FML FORTEQ suspension to insert soft contact lenses.
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`Carcinogenesis, Mutagenesis, Impairment of Fertility
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`No studies have been conducted in animals or in humans to evaluate the possibility of these
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`Pregnancy
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`Teratogenic effects. Pregnancy Category C
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`Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when
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`administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly
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`to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities
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`including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as
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`encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and
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`well-controlled studies of fluorometholone in pregnant women, and it is not known whether
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`fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone
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`should be used during pregnancy only if the potential benefit justifies the potential risk to the
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`Reference ID: 3258817
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`NDA 19-216/S-025
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`Page 6
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`fetus.
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`Nursing Mothers
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`It is not known whether topical ophthalmic administration of corticosteroids could result in
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`sufficient systemic absorption to produce detectable quantities in human milk. Systemically
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`administered corticosteroids appear in human milk and could suppress growth, interfere with
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`endogenous corticosteroid production, or cause other untoward effects. Because of the potential
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`for serious adverse reactions in nursing infants from fluorometholone, a decision should be made
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`whether to discontinue nursing or to discontinue the drug, taking into account the importance of
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`the drug to the mother.
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`Pediatric Use
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`Safety and effectiveness in infants below the age of two years have not been established.
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`Geriatric Use
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`No overall differences in safety or effectiveness have been observed between elderly and
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`ADVERSE REACTIONS
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`Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure
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`(IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior
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`subcapsular cataract formation, and delayed wound healing.
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`Although systemic effects are extremely uncommon, there have been rare occurrences of
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`systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin.
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`Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis
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`and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival
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`hyperemia, loss of accommodation and ptosis have occasionally been reported following local
`use of corticosteroids.
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`The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal
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`and viral infections of the cornea are particularly prone to develop coincidentally with long-term
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`applications of steroids. The possibility of fungal invasion should be considered in any persistent
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`corneal ulceration where steroid treatment has been used (see WARNINGS).
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`Transient burning and stinging upon instillation and other minor symptoms of ocular irritation
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`have been reported with the use of FML FORTEG suspension. Other adverse events reported
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`with the use of fluorometholone include: allergic reactions; foreign body sensation; erythema of
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`eyelid; eyelid edema/eye swelling; eye discharge; eye pain; eye pruritus; lacrimation increased;
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`rash; taste perversion; visual disturbance (blurry vision); and visual field defect.
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`Reference ID: 3258817
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`NDA 19-216/S-025
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`Page 7
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`DOSAGE AND ADMINISTRATION
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`Shake well before using. Instill one drop into the conjunctival sac two to four times daily.
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`During the initial 24 to 48 hours, the dosing frequency may be increased to one application every
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`four hours. Care should be taken not to discontinue therapy prematurely.
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`If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see
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`PRECAUTIONS).
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`The dosing of FML FORTE® suspension may be reduced, but care should be taken not to
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`discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be
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`carried out by gradually decreasing the frequency of applications.
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`HOW SUPPLIED
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`FML FORTEG’ (fluorometholone ophthalmic suspension, USP) 0.25% is supplied sterile in
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`opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS)
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`caps as follows:
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`5 mL in 10 mL bottle - NDC 11980-228-05
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`10 mL in 15 mL bottle - NDC 11980-228-10
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`15 mL in 15 mL bottle - NDC 11980-228- 15
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`Storage: Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position.
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`Revised: 02/2013
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`© 2013 Allergan, Inc.
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`Irvine, CA 92612, U.S.A.
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`® marks owned by Allergan, Inc.
`Made in the U.S.A.
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`Reference ID: 3258817
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`yv