`
`SUPPLEMENT APPROVAL
`
`
`Novartis Pharmaceuticals Corporation
`
`Attention: Katerina Tsironi, MBA
`Sr. Global Program Regulatory Manager, Regulatory Affairs
`
`One Health Plaza
`East Hanover, NJ 07936-1080
`
`
`Dear Ms. Tsironi:
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`November 22, 2019, and your amendments, submitted under section 505(b) of the
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for VIGAMOX (moxifloxacin ophthalmic
`solution). This Prior Approval supplemental new drug application provides for revisions
`to the Prescribing Information to comply with the content and format requirements of the
`
`Pregnancy and Lactation Labeling Rule (PLLR).
`
`APPROVAL & LABELING
`
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`
`
`Prescribing Information), 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 SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`Reference ID: 4604666
`
`
`
`NDA 21598/S-023
`Page 2
`
`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 Derek Alberding, Regulatory Health Project Manager, at
`(240) 402-0963.
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`Wiley A. Chambers, M.D.
`(Acting) Director
`Division of Ophthalmology
`Office of Specialty Medicine
`
`Center for Drug Evaluation and Research
`
`ENCLOSURE:
` Content of Labeling
`o Prescribing Information
`
`Reference ID: 4604666
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`WILEY A CHAMBERS
`05/11/2020 05:38:25 PM
`
`Reference ID: 4604666
`
`(
`
`
`
`
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