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`NDA 208144/S-013
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`Bausch & Lomb Incorporated
`Attention: Shaun A. Mbithi
`Associate Director, Global Regulatory Affairs
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Dear Ms. Mbithi:
`
`SUPPLEMENT APPROVAL
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`June 16, 2021, and your amendments, submitted under section 505(b)(2) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Lumify (brimonidine tartrate) ophthalmic
`solution.
`
`This “Prior Approval” supplemental new drug application provides for the addition of a
`new 2 X 5 mL twin pack carton configuration.
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`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.
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`LABELING
`
`Submit final printed labeling (FPL), as soon as they are available, but no more than 30
`days after they are printed. The FPL must be identical to the enclosed labeling,
`described in the table below and must be in the “Drug Facts” format (21 CFR 201.66),
`where applicable.
`
`Submitted Draft Labeling
`Lumify 2 x 5 mL (0.17 fl oz) twin pack carton
`
`Date Submitted
`November 12, 2021
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`Eye Therapies Exhibit 2063, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
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`
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`NDA 208144/S-013
`Page 2
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`The FPL should be submitted electronically according to the guidance for industry
`Providing Regulatory Submissions in Electronic Format — Certain Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications.1 For administrative purposes, designate this submission “Final Printed
`Labeling for approved NDA 208144/S-013.” Approval of this submission by FDA is not
`required before the labeling is used.
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`DRUG REGISTRATION AND LISTING
`
`All drug establishment registration and drug listing information is to be submitted to FDA
`electronically, via the FDA automated system for processing structured product labeling
`(SPL) files (eLIST). At the time that you submit your final printed labeling (FPL), the
`content of labeling (Drug Facts) should be submitted in SPL format as described at
`FDA.gov.2 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. In
`addition, representative container or carton labeling, whichever includes Drug Facts,
`(where differences exist only in the quantity of contents statement) should be submitted
`as a JPG file.
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`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, contact Michael Boblitz, PharmD, Regulatory Project
`Manager at Michael.Boblitz@fda.hhs.gov or (301) 837-7651.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Francis E. Becker, MD, FACP
`Director
`Division of Nonprescription Drugs II
`Office of Nonprescription Drugs
`Center for Drug Evaluation and Research
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`1 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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`2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
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`Eye Therapies Exhibit 2063, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
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`NDA 208144/S-013
`Page 3
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`ENCLOSURE(S):
`• Carton Labeling
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
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`Eye Therapies Exhibit 2063, 3 of 4
`Slayback v. Eye Therapies - IPR2022-00142
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`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/
`------------------------------------------------------------
`
`FRANCIS E BECKER
`11/29/2021 01:32:18 PM
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`(
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`Eye Therapies Exhibit 2063, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
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