DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`NDA 21994/S-012
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Novartis Pharmaceuticals Corporation
`Attention: Phillip Reveal, MS
`Regulatory Affairs Global Franchise Pharmaceuticals Ophthalmology
`6201 South Freeway, Mail Stop TC-45
`Fort Worth, TX 76134-2099
`
`Dear Mr. Reveal:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`March 22, 2017, and your amendments submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act for Travatan Z (travoprost ophthalmic solution) 0.004%.
`
`This “Prior Approval” labeling supplement to your application proposes the addition of a new
`section 6.2 Postmarketing Experience and additional minor editorial and formatting revisions.
`
`APPROVAL & LABELING
`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text which is identical to the labeling submitted on September 19, 2017.
`
`CONTENT OF LABELING
`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 the enclosed package insert labeling, 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.
`
`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. The SPL will be accessible from publicly available labeling repositories.
`Also within 14 days, amend all pending supplemental applications that include labeling changes
`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 approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`
`Reference ID: 4156862
`
`

`

`NDA 21994/S-012
`Page 2
`
`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 and annual report date.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`Submit final printed carton and immediate container labels that are identical to the enclosed
`carton and immediate container labels submitted on September 19, 2017, as soon as they are
`available, but no more than 30 days after they are printed. Please submit these labels
`electronically according to the guidance for industry Providing Regulatory Submissions in
`Electronic Format – Human Pharmaceutical Product Applications and Related Submissions
`Using the eCTD Specifications (June 2008). Alternatively, you may submit 12 paper copies,
`with 6 of the copies individually mounted on heavy-weight paper or similar material. For
`administrative purposes, designate this submission “Final Printed Carton and Container
`Labels for approved NDA 21994/S-012.” Approval of this submission by FDA is not required
`before the labeling is used.
`
`REPORTING REQUIREMENTS
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Michael Puglisi, Regulatory Project Manager, at (301) 796-0791.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Wiley A. Chambers, M.D.
`Deputy Director
`Division of Transplant and Ophthalmology Products
`Office of Antimicrobial Products
`Office of New Drugs
`Center for Drug Evaluation and Research
`
`ENCLOSURE:
`Carton and Container Labeling
`Content of Labeling
`
`Reference ID: 4156862
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`WILEY A CHAMBERS
`09/22/2017
`
`Reference ID: 4156862
`
`