`
`NDA 22288/S-008
`
`Bausch and Lomb, Inc.
`c/o Valeant Pharmaceuticals North America LLC
`Attention: Ms. Helen Sun
`Associate Director, US Regulatory Affairs
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Dear Ms. Sun:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`August 15, 2017, under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Bepreve (bepotastine besilate ophthalmic solution), 1.5%.
`
`This supplemental new drug application provides for revisions to the package insert to comply
`with the Pregnancy and Lactation Labeling Rule (PLLR) as well as various editorial changes.
`
`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 with a minor editorial change to Section 13.2. The redundant word “that” in the last sentence
`of the first paragraph should be deleted.
`
`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, 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.
`
`Reference ID: 4218555
`
`
`
`NDA 22288/S-008
`Page 2
`
`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-
`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 Wendy Streight, Ph.D., Regulatory Project Manager, at
`(301) 796-1600.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Wiley A. Chambers, M.D.
`Deputy Director
`Division of Transplant and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`ENCLOSURE:
`Content of Labeling
`
`Reference ID: 4218555
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`02/09/2018
`
`Reference ID: 4218555
`
`
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