SUPPLEMENT APPROVAL
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`NDA 21994/S-013
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`
`Novartis Pharmaceuticals Corporation
`Attention: Suzanne Brabant
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`Global Program Regulatory Director
`
`One Health Plaza
`East Hanover, NJ 07936-1080
`
`
`Dear Ms. Brabant:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`April 4, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
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`Act (FDCA) for TRAVATAN Z (travoprost ophthalmic solution). We acknowledge receipt
`of your amendment dated September 26, 2019, which constituted a complete response
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`
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`to our October 4, 2018, action letter. This Prior Approval supplemental new drug
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`application provides for revisions to the Prescribing Information to comply with the
`content and format requirements of the Pregnancy and Lactation Labeling Rule (PLLR).
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`APPROVAL & LABELING
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`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
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`with minor editorial revisions reflected in the enclosed labeling.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`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
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`Prescribing Information), with the addition of any labeling changes in pending “Changes
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible from publicly available labeling repositories.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`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.
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`Reference ID: 4580586
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`

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`NDA 21994/S-013
`Page 2
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` Also within 14 days, amend all pending supplemental applications that include labeling
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`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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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`Word version. The marked-up copy should provide appropriate annotations, including
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`supplement number(s) and annual report date(s).
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the carton and
`container labeling submitted on September 26, 2019, as soon as they are available, but
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`no more than 30 days after they are printed. Please submit these labeling electronically
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`according to the guidance for industry Providing Regulatory Submissions in Electronic
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`Format — Certain Human Pharmaceutical Product Applications and Related
`Submissions Using the eCTD Specifications. For administrative purposes, designate
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`this submission “Final Printed Carton and Container Labeling for approved
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`NDA 21994/S-013.” Approval of this submission by FDA is not required before the
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`labeling is used.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Derek Alberding, Regulatory Health Project Manager, at
`(240) 402-0963.
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`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
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`ENCLOSURE:
` Content of Labeling
`o Prescribing Information
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`Reference ID: 4580586
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`

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`Signature Page 1 of 1
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`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/
`------------------------------------------------------------
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`WILEY A CHAMBERS
`04/02/2020 01:38:43 PM
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`Reference ID: 4580586
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