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`SENJU EXHIBIT 2053
`LUPIN v SENJU
`IPR2015-01100
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`OCUFEN® ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of
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`the medication.
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`CONTRAINDICATIONS
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`WARNINGS
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`With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference
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`with thrombocyte aggregation. There have been reports that OCUFEN® ophthalmic solution may cause
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`increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
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`There exists the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory
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`drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities
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`to these drugs.
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`PRECAUTIONS
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`General: Wound healing may be delayed with the use of OCUFEN® (flurbiprofen sodium ophthalmic solution,
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`USP) 0.03%.
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`It is recommended that OCUFEN® be used with caution in surgical patients with known bleeding tendencies or
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`who are receiving other medications which may prolong bleeding time.
`Drug interactions:
`Interaction of OCUFENG’ ophthalmic solution with other topical ophthalmic medications
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`has not been fully investigated.
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`Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol
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`revealed no interference, and there is no known pharrnacological basis for an interaction, there have been
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`reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with
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`OCUFEN®.
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`Carcinogenesis, Mutagenesis, impairment of fertility: Long-tenn studies in mice and/or rats have shown
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`no evidence of carcinogenicity with flurbiprofen.
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`Long-tenn mutagenicity studies in animals have not been performed.
`Pregnancy:
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`Pregnancy category C: Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation,
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`reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg
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`(approximately 190 times the human daily topical dose) and above. There are no adequate and well-
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`controlled studies in pregnant women.
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`OCUFEN“’ ophthalmic solution should be used during pregnancy only if the potential benefit justifies the
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`potential risk to the fetus.
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`Nursing mothers:
`It’ is not known whether this drug is excreted in human milk. Because many drugs are
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`excreted in human milk and because of the potential for serious adverse reactions in nursing infants from
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`flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug,
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`taking into account the importance of the drug to the mother.
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`Pediatric use: Safety and effectiveness in pediatric patients have not been established.
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`Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and
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`younger patients.
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`PAGE 2 OF 4
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`PAGE 2 OF 4
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`ADVERSE REACTIONS
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`Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been
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`reported with the use of OCUFEN® ophthalmic solution. Other adverse reactions reported with the use of
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`OCUFEN® include: fibrosis, miosis, and mydriasis.
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`increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.
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`Overdosage will not ordinarily cause acute problems.
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`It accidentally ingested, drink fluids to dilute.
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`OVERDOSAGE
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`DOSAGE AND ADMINISTRATION
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`A total of four (4) drops of OCUFEN"” ophthalmic solution should be administered by instilling one (1) drop
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`approximately every 1/2 hour beginning 2 hours before surgery.
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`HOW SUPPLIED
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`OCUFEN® (llurbiprofen sodium ophthalmic solution, USP) is available for topical ophthalmic administration as
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`a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled
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`dropper tip and a white high impact polystyrene cap in the following size:
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`2.5 mL - NDC 11980-801-03
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`Note: Store at room temperature.
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`Rx only
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`Revised May 2001
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`® Registered trademarks of Allergan, Inc
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`Allergan, Inc.
`Irvine, California 92612. U.S.A.
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`© 2001 Allergan, lnc.
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`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
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` /s/
`---------------------
`Linda Ng
`8/17/01 06:39:46 PM
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