(~ II U.S. FOOD & DRUG
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`ADMINISTRATION
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`\~,,.~~'-
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` NDA 208144/S-013
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` SUPPLEMENT APPROVAL
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`Bausch & Lomb Incorporated
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`Attention: Shaun A. Mbithi
` Associate Director, Global Regulatory Affairs
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` 400 Somerset Corporate Boulevard
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` Bridgewater, NJ 08807
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` Dear Ms. Mbithi:
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` Please refer to your supplemental new drug application (sNDA) dated and received
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` 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
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` solution.
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`This “Prior Approval” supplemental new drug application provides for the addition of a
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` new 2 X 5 mL twin pack carton configuration.
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` APPROVAL & LABELING
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` We have completed our review of this application, as amended. It is approved, effective
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` on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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` LABELING
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`Submit final printed labeling (FPL), as soon as they are available, but no more than 30
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` 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),
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` where applicable.
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` Submitted Draft Labeling
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` Lumify 2 x 5 mL (0.17 fl oz) twin pack carton
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` Date Submitted
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` November 12, 2021
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`Reference ID: 4895516
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` NDA 208144/S-013
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` Page 2
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` The FPL should be submitted electronically according to the guidance for industry
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`Providing Regulatory Submissions in Electronic Format — Certain Human
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` Pharmaceutical Product Applications and Related Submissions Using the eCTD
` Specifications.1 For administrative purposes, designate this submission “Final Printed
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`Labeling for approved NDA 208144/S-013.” Approval of this submission by FDA is not
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` required before the labeling is used.
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` DRUG REGISTRATION AND LISTING
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` All drug establishment registration and drug listing information is to be submitted to FDA
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`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
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` 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
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` addition, representative container or carton labeling, whichever includes Drug Facts,
`(where differences exist only in the quantity of contents statement) should be submitted
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` as a JPG file.
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` REPORTING REQUIREMENTS
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` We remind you that you must comply with reporting requirements for an approved NDA
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` (21 CFR 314.80 and 314.81).
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`If you have any questions, contact Michael Boblitz, PharmD, Regulatory Project
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` Manager at Michael.Boblitz@fda.hhs.gov or (301) 837-7651.
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` Sincerely,
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` {See appended electronic signature page}
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` Francis E. Becker, MD, FACP
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` Director
` Division of Nonprescription Drugs II
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` 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
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` 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
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` Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 4895516
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` NDA 208144/S-013
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` Page 3
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` ENCLOSURE(S):
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`• Carton Labeling
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` U.S. Food and Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 4895516
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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/
`------------------------------------------------------------
`
`FRANCIS E BECKER
`11/29/2021 01:32:18 PM
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`I
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`Reference ID: 4895516
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`(
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