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`(/Portals/77/-/m/BL/United
`States/Files/Package
`Inserts/Pharma/lotemax-
`package-insert.pdf?ver=2016-
`09-26-093910-470)
`(153
`KB)
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`Your-Practice)
`Products)
`Resources)
`Ordering)
`Home (/ecp/)
`... Rx Pharmaceuticals (http://www.bausch.com/ecp/Our-Products/Rx-Pharmaceuticals) Rx
`Pharmaceuticals (http://www.bausch.com/ecp/Our-Products/Rx-Pharmaceuticals/Rx-Pharmaceuticals) Lotemax
`(Loteprednol Etabonate Ophthalmic Suspension 0.5%) (Http://Www.bausch.com/Ecp/Our-Products/Rx-Pharmaceuticals/Rx-
`Pharmaceuticals/Lotemax-Ecp)
`
`Lotemax (loteprednol etabonate ophthalmic suspension)
`0.5%
`
`Lotemax is indicated for the treatment of steroid responsive inflammatory conditions
`of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe,
`such as allergic conjunctivitis, acne, rosacea, superficial punctate keratitis, herpes
`zoster keratitis, iritis, cyclitis, and selected infective conjunctivides, when the
`inherent hazard of steroid use is accepted to obtain an advisable diminution in
`edema and inflammation.
`
`Lotemax is less effective than prednisolone acetate 1% in two 28-day controlled
`clinical studies in acute anterior uveitis, where 72% of patients treated with Lotemax
`experienced resolution of anterior chamber cells, compared to 87% of patients
`treated with prednisolone acetate 1%. The incidence of patients with clinically
`significant increases in IOP (>10 mm Hg) was 1% with Lotemax and 6% with
`prednisolone acetate 1%. Lotemax should not be used in patients who require a
`more potent corticosteroid for this indication.
`
`Lotemax is also indicated for the treatment of post-operative inflammation following ocular surgery.
`
`IMPORTANT SAFETY INFORMATION
`• Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex
`keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of
`ocular structures. Lotemax is also contraindicated in individuals with known or suspected hypersensitivity to any of the
`ingredients of this preparation and to other corticosteroids.
`
`• Prolonged use of Lotemax is associated with several warnings and precautions, including glaucoma with optic nerve
`damage, defects in visual acuity and fields of vision, cataract formation, secondary ocular infections, occurrence of
`perforations in those with diseases causing corneal and scleral thinning, exacerbation or prolongation of viral ocular
`infections (including herpes simplex), delay in wound healing and increase in bleb formation following cataract surgery.
`
`• If this product is used for 10 days or longer, intraocular pressure should be monitored. The initial prescription and renewal
`of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of
`magnification. Fungal infections of the cornea may develop with prolonged use of corticosteroids.
`
`• Ocular adverse reactions occurring in 5%-15% of patients treated with loteprednol etabonate ophthalmic suspension
`(0.2% - 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes,
`epiphora, foreign body sensation, itching, injection and photophobia.
`
`Please click here (/Portals/77/-/m/BL/United States/Files/Package Inserts/Pharma/lotemax-package-insert.pdf?ver=2016-09-
`26-093713-477)
` (354.4 KB, PDF) to view the Lotemax full Prescribing Information.
`
`LES.0016.USA.16
`
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`your-practice/resource-
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`overview/)
`Contact Lenses (/ecp/our-
`products/contact-lenses)
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`OTC Ophthalmics (/ecp/our-
`products/otc-ophthalmics/)
`Eye Vitamins (/ecp/our-
`products/eye-vitamins)
`Rx Pharmaceuticals (/ecp/our-
`products/rx-
`pharmaceuticals/rx-
`pharmaceuticals-ecp/)
`© 2017 Bausch & Lomb Incorporated.
`Orthokeratology (/ecp/our-
`products/orthokeratology)
`All information and materials on this site pertain to the U.S. only, unless otherwise indicated.
`
`Legal Notice (/reference/legal-
`notice/)
`Privacy Policy
`(/reference/privacy-policy/)
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`materials/material-safety-data-
`sheets)
`
`http://www.bausch.com/ecp/our-products/rx-pharmaceuticals/rx-pharmaceuticals/lotemax-ecp
`
`MYLAN - EXHIBIT 1090
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`
`
`For Consumers
`
`(/)
`
`Text size A- A+
`
`Search...
`
`Learn More
`
`Please see Prescribing
`Information.
`(/Portals/77/-/m/BL/United
`States/Files/Package
`Inserts/Pharma/lotemax-
`package-insert.pdf?ver=2016-
`09-26-093910-470)
`(153
`KB)
`
`Newsroom (/our-
`company/recent-news/)
`Careers (/our-
`company/careers/)
`Investor Relations (/our-
`company/investor-relations/)
`Grants & Contributions (/our-
`company/grants-and-
`charitable-contributions/grants-
`and-charitable-contributions-
`landing)
`
`United States
`
`Home (/ecp/)
`
`Newsroom (/our-
`company/recent-news/)
`
`(/ecp/)
`
`Worldwide Locations
`Careers (/our-
`(/our-
`company/careers/)
`company/worldwide-
`Online Ordering
`For Your Practice
`Clinical Resources
`Our Products
`(http://www.bausch.com/ecp/Our-(http://www.bausch.com/ecp/Clinical-(http://www.bausch.com/ecp/For-(http://www.bausch.com/ecp/Online-
`
`
`
`locations/)
`Your-Practice)
`Products)
`Resources)
`Ordering)
`Home (/ecp/)
`... Rx Pharmaceuticals (http://www.bausch.com/ecp/Our-Products/Rx-Pharmaceuticals) Rx
`Pharmaceuticals (http://www.bausch.com/ecp/Our-Products/Rx-Pharmaceuticals/Rx-Pharmaceuticals) Lotemax
`(Loteprednol Etabonate Ophthalmic Suspension 0.5%) (Http://Www.bausch.com/Ecp/Our-Products/Rx-Pharmaceuticals/Rx-
`Pharmaceuticals/Lotemax-Ecp)
`
`Lotemax (loteprednol etabonate ophthalmic suspension)
`0.5%
`
`Lotemax is indicated for the treatment of steroid responsive inflammatory conditions
`of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe,
`such as allergic conjunctivitis, acne, rosacea, superficial punctate keratitis, herpes
`zoster keratitis, iritis, cyclitis, and selected infective conjunctivides, when the
`inherent hazard of steroid use is accepted to obtain an advisable diminution in
`edema and inflammation.
`
`Lotemax is less effective than prednisolone acetate 1% in two 28-day controlled
`clinical studies in acute anterior uveitis, where 72% of patients treated with Lotemax
`experienced resolution of anterior chamber cells, compared to 87% of patients
`treated with prednisolone acetate 1%. The incidence of patients with clinically
`significant increases in IOP (>10 mm Hg) was 1% with Lotemax and 6% with
`prednisolone acetate 1%. Lotemax should not be used in patients who require a
`more potent corticosteroid for this indication.
`
`Lotemax is also indicated for the treatment of post-operative inflammation following ocular surgery.
`
`IMPORTANT SAFETY INFORMATION
`• Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex
`keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of
`ocular structures. Lotemax is also contraindicated in individuals with known or suspected hypersensitivity to any of the
`ingredients of this preparation and to other corticosteroids.
`
`• Prolonged use of Lotemax is associated with several warnings and precautions, including glaucoma with optic nerve
`damage, defects in visual acuity and fields of vision, cataract formation, secondary ocular infections, occurrence of
`perforations in those with diseases causing corneal and scleral thinning, exacerbation or prolongation of viral ocular
`infections (including herpes simplex), delay in wound healing and increase in bleb formation following cataract surgery.
`
`• If this product is used for 10 days or longer, intraocular pressure should be monitored. The initial prescription and renewal
`of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of
`magnification. Fungal infections of the cornea may develop with prolonged use of corticosteroids.
`
`• Ocular adverse reactions occurring in 5%-15% of patients treated with loteprednol etabonate ophthalmic suspension
`(0.2% - 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes,
`epiphora, foreign body sensation, itching, injection and photophobia.
`
`Please click here (/Portals/77/-/m/BL/United States/Files/Package Inserts/Pharma/lotemax-package-insert.pdf?ver=2016-09-
`26-093713-477)
` (354.4 KB, PDF) to view the Lotemax full Prescribing Information.
`
`LES.0016.USA.16
`
`Professional Resources
`
`Products
`
`Customer Support
`
`Legal
`
`Worldwide Locations (/our-
`company/worldwide-locations)
`Customer policies and forms
`(/reference/customer-policies-
`and-forms/)
`Customer Commitment &
`Partnership (/ecp/for-your-
`practice/resource-
`materials/customer-
`commitment-and-partnership)
`
`Meetings and Exhibits
`(/ecp/for-your-
`practice/professional-
`calendar/meetings-and-
`exhibits/)
`Educational Meetings/Dinners
`(/ecp/for-your-
`practice/professional-
`calendar/education/)
`Resource Materials (/ecp/for-
`your-practice/resource-
`materials/)
`Training & Tools (/ecp/for-your-
`practice/training/)
`
`Online Ordering (/ecp/online-
`ordering/online-ordering-
`overview/)
`Contact Lenses (/ecp/our-
`products/contact-lenses)
`Contact Lens Care (/ecp/our-
`products/contact-lens-care/)
`OTC Ophthalmics (/ecp/our-
`products/otc-ophthalmics/)
`Eye Vitamins (/ecp/our-
`products/eye-vitamins)
`Rx Pharmaceuticals (/ecp/our-
`products/rx-
`pharmaceuticals/rx-
`pharmaceuticals-ecp/)
`© 2017 Bausch & Lomb Incorporated.
`Orthokeratology (/ecp/our-
`products/orthokeratology)
`All information and materials on this site pertain to the U.S. only, unless otherwise indicated.
`
`Legal Notice (/reference/legal-
`notice/)
`Privacy Policy
`(/reference/privacy-policy/)
`Safety Data Sheets (SDS)
`(/ecp/for-your-
`practice/resource-
`materials/material-safety-data-
`sheets)
`
`http://www.bausch.com/ecp/our-products/rx-pharmaceuticals/rx-pharmaceuticals/lotemax-ecp
`
`MYLAN - EXHIBIT 1090
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`
`
`
`
`Cataract Surgery (/ecp/our-
`
`Page 2 of 2
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`http://www.bausch.com/ecp/our-products/rx-pharmaceuticals/rx-pharmaceuticals/lotemax-ecp
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