`
` DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`NDA 21598/S-022
`
`Alcon Pharmaceuticals, Ltd.
`
`c/o Alcon Research, Ltd.
`Attention: Damon Daulerio
`Head, Project Support Pharma/ Regulatory Affairs
`6201 South Freeway, R3-50
`Fort Worth, TX 76134-2099
`
`Dear Mr. Daulerio:
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`September 30, 2016, and your amendments, submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for VIGAMOX (moxifloxacin ophthalmic solution) 0.5%.
`
`This “Prior Approval” labeling supplement to your application provides for revision of the
`established name of the drug product in all labeling to be consistent with the current USP
`Monograph for moxifloxacin ophthalmic solution, as requested in the Agency’s supplement
`
`request letter of May 31, 2016. There are also revisions to Sections 8.4 and 12 as required by
`
`the Best Pharmaceuticals for Children Act (BPCA). In Section 17, there are added subheadings
`and revised patient counseling information. Minor additional editorial revisions to the labeling
`have also been included.
`
`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 February 16, 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.
`
`Reference ID: 4068949
`
`

`

`NDA 21598/S-022
`Page 2
`
`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-
`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).
`
`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 October 25, 2016, 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 21598/S-022.” 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:
`Content of Labeling
`
`Carton and Container Labeling
`
`Reference ID: 4068949
`
`

`

`---------------------------------------------------------------------------------------------------------
`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
`03/14/2017
`
`Reference ID: 4068949
`
`