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`DEPARTMENTOFHEALTH&HUMANSERVICES
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`Food and Drug Administration
`Rockville, MD 20857
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`PublicHealthService
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`NDA21-994
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`Alcon,Inc.
`c/o Alcon Research, Ltd.
`Attention: Angela C. Kothe, O.D., Ph.D.
`Associate Director, Regulatory Affairs
`Mail Code R7-18
`6201 South Freeway
`Fort Worth, Texas 76134-2099
`
`Dear Dr. Kothe:
`
`Please refer to your new drug application (NDA) dated November18, 2005, received
`November21, 2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`for Travatan Z (travoprost ophthalmic solution) 0.004%.
`
`We acknowledge receipt of your submissions dated November 18, and December7 and 14, 2005, and
`January 10, March 15, July 25, August 15, and September1, 6, 15, and 18, 2006.
`
`This new drug application provides for the use of Travatan Z for the reduction of elevated intraocular
`pressure in patients with open angle glaucomaor ocular hypertension whoare intolerant of other
`intraocular pressure lowering medicationsor insufficiently responsive (failed to achieve target IOP
`determined after multiple measurements over time) to other intraocular pressure lowering medications.
`
`We completed our review of this application, as amended. It is approved, effective on the date of this
`letter, for use as recommendedin the agreed-upon labeling text.
`
`Thefinal printed labeling (FPL) must be identical to the enclosed draft labeling submitted on
`September 15, 2006. Marketing the product with FPL that is not identical to the approved labeling text
`may render the product misbranded and an unapproved new drug. Please submit the content of the
`labeling [21 CFR 314.50(1)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/oc/datacouncil/spl.html, that is identical to the enclosed draft labeling. Upon
`receipt and verification, we will transmit that version to the National Library of Medicine for posting
`on the DailyMed website.
`
`ALCON 2060
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`€
`
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`NDA 21-994
`Page 2
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`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`and this division and two copies of both the promotional materials and the package insert directly to:
`
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
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`Please submit one market package of the drug product when it is available.
`
`We remind you that you must comply with reporting requirements for an approved NDA (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.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Janice M. Soreth, M.D.
`Director
`Division of Anti-Infective and
`Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Enclosure
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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/
`---------------------
`Janice Soreth
`9/21/2006 03:22:29 PM
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