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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-257/S-018
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`Food and Drug Administration
`Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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`Alcon Universal, Ltd.
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`c/o Alcon Research, Ltd.
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`Attention: Angela C. Kothe, O.D., Ph.D.
`Director, Regulatory Affairs
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`6201 South Freeway
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`Fort Worth, Texas 76134-2099
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`Dear Dr. Kothe:
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`Please refer to your supplemental new drug application dated June 1, 2006, received
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`June 2, 2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Travatan (travoprost ophthalmic solution) 0.004%.
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`We acknowledge receipt of your submissions dated September 27, 2006, March 29, 2007,
`June 24, 2008, and July 7 and 13, and August 19, 2010.
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`This “Prior Approval” supplemental new drug application provides for the use of Travatan
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`(travoprost ophthalmic solution) 0.004% for the reduction of elevated intraocular pressure in
`patients with open angle glaucoma or ocular hypertension.
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
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`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
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`identical to the enclosed labeling (text for the package insert) and include the labeling changes
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`proposed in any pending “Changes Being Effected” (CBE) supplements. Information on
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`submitting SPL files using eLIST may be found in the guidance for industry titled “SPL
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`Standard for Content of Labeling Technical Qs and As” at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications for this NDA, including
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`pending “Changes Being Effected” (CBE) supplements, for which FDA has not yet issued an
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`Exhibit 1051
`ARGENTUM
`IPR2017-01053
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`000001
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`

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`NDA 21-257/S-018
`Page 2
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format that
`includes the changes approved in this supplemental application.
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` Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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` active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
` administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`We are waiving the pediatric study requirement for this application because there is evidence
`suggesting that the drug product would be unsafe in all pediatric age groups. There are potential
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`safety concerns related to increased pigmentation following long-term chronic use of the drug
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`product.
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.(b)(3)(i)]. Form FDA
`2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions
`are provided on page 2 of the form. For more information about submission of promotional
`materials to the Division of Drug Marketing, Advertising, and Communications (DDMAC), see
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`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`If you decide to issue a letter communicating important safety-related information about this
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`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
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`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA, to
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`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`000002
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`

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`NDA 21-257/S-018
`Page 3
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Michael Puglisi, Project Manager, at (301) 796-0791.
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`Sincerely,
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`{See appended electronic signature page}
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` Wiley A. Chambers, M.D.
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`Acting Director
`Division of Anti-Infective
`and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Enclosure:
`Content of Labeling
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`000003
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`Application
`Type/Number
`--------------------
`NDA-21257
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`Submission
`Type/Number
`--------------------
`SUPPL-18
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`Submitter Name
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`Product Name
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`--------------------
`ALCON INC
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`------------------------------------------
`TRAVATAN(TRAVOPROST
`OPHTHALMIC SOLUTION)
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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.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`WILEY A CHAMBERS
`08/31/2010
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`000004
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