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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-994/S-006
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Alcon Pharmaceuticals, Ltd.
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`c/o Alcon Research, Ltd.
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`Attention: Angela C. Kothe, O.D., Ph.D.
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`Senior Director, Regulatory Affairs
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`6201 South Freeway, Mail Code R3-52
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`Fort Worth, TX 76134-2099
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`Dear Dr. Kothe:
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`Please refer to your Supplemental New Drug Application (sNDA) dated August 19, 2011,
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`received August 22, 2011, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Travatan Z (travoprost ophthalmic solution) 0.004%.
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`This “Prior Approval” supplemental new drug application provides for a revision to the Adverse
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`Reactions section of the package insert to include additional information resulting from
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`postmarketing use of prostaglandin analogues.
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`We have completed our review of this supplemental application. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text and with
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`the minor editorial revisions listed below.
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`Correct the proprietary drug name listed in Section 17.5 Use with Contact Lenses to read
`TRAVATAN Z.
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to, except with the revisions indicated, the enclosed labeling (text
`for the package insert) with the addition of any labeling changes in pending “Changes Being
`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
`labeling.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`Reference ID: 3009257
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` NDA 21-994/S-006
`Page 2
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`The SPL will be accessible via publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications for this NDA, including CBE
`supplements for which FDA has not yet issued an action letter, with the content of labeling
`[21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes with the revisions
`indicated above approved in this supplemental application, as well as annual reportable changes,
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`and annotate each change. To facilitate review of your submission, provide a highlighted or
`marked-up copy that shows all changes, as well as a clean Microsoft Word version. The marked-
`up copy should provide appropriate annotations, including supplement number(s) and annual
`report date(s).
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`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
`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 314.81(b)(3)(i)]. Form
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`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 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`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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`Reference ID: 3009257
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` NDA 21-994/S-006
`Page 3
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`If you have any questions regarding this supplemental application, please contact Ms. Leanna
`Kelly, Consumer Safety Officer, at (301) 796-0471. For all other inquiries regarding this NDA,
`please contact Mr. Michael Puglisi, Regulatory 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.
`Deputy Director
`Division of Transplant 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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`Reference ID: 3009257
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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
`09/07/2011
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`Reference ID: 3009257
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