`
`NDA 50790/S-027
`
`Allergan, Inc.
`Attention: Linda McCauley, PhD
`Senior Manager, Regulatory Affairs
`2525 Dupont Drive, PO Box 19534
`Irvine, CA 92612
`
`Dear Dr. McCauley:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated February 17, 2017,
`received February 17, 2017, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for RESTASIS (cyclosporine ophthalmic
`emulsion) 0.05%. Supplement 027 proposes revision of the package insert to conform to the
`Pregnancy and Lactation Labeling Rule (PLLR) format, and proposes minor editorial revisions
`to the RESTASIS MULTIDOSE (cyclosporine ophthalmic emulsion) 0.05% package insert.
`
`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.
`
`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 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.
`
`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
`
`Reference ID: 4126070
`
`
`
`NDA 50790/S-027
`
`2
`
`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).
`
`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 Jacquelyn Smith, MA, Senior Regulatory Project Manager, at
`(301) 796-1600.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Wiley A. Chambers, MD
`Deputy Director
`Division of Transplant and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`Content of Labeling
`
`Reference ID: 4126070
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`07/18/2017
`
`Reference ID: 4126070
`
`(
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