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` NDA 218424
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` NDA APPROVAL
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`Bausch & Lomb Incorporated
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`Attention: Shaun A. Mbithi
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`Director, Global Regulatory Affairs
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`400 Somerset Corporate Blvd
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`Bridgewater, NJ 08807
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`Dear Shaun Mbithi:
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`Please refer to your new drug application (NDA) dated and received May 2, 2023, and
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`your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
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`and Cosmetic Act (FDCA) for Lumify Preservative Free (brimonidine tartrate)
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`ophthalmic solution, 0.025%.
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`We acknowledge receipt of your major amendment dated January 31, 2024, which
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`extended the goal date by three months.
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`This new drug application provides for the use of Lumify Preservative Free (brimonidine
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`tartrate) ophthalmic solution, 0.025% for relief of redness of the eye due to minor eye
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`irritations.
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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 agreed-upon labeling text.
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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 final printed labeling must be identical to the enclosed
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`labeling, described in the table below, and must be in the “Drug Facts” format (21 CFR
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`201.66), where applicable.
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`Submitted Draft Labeling
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` Lumify Preservative Free Foil Pouch – Trade (5 count)
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` Lumify Preservative Free 0.4 mL Vial
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` Lumify Preservative Free Carton (20 count)
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` Lumify Preservative Free Foil Pouch – Sample (5 count)
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`Date Submitted
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` May 2, 2023
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` May 2, 2023
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` December 12, 2023
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` December 12, 2023
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`The final printed labeling should be submitted electronically according to the guidance
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`for industry Providing Regulatory Submissions in Electronic Format — Certain Human
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`Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Reference ID: 5367316
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` NDA 218424
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` Page 2
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`Specifications.1 For administrative purposes, designate this submission “Final Printed
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`Labeling for approved NDA 218424.” 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
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`(SPL) files (eLIST). At the time that you submit your final printed labeling (FPL), the
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`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
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`guidance for industry SPL Standard for Content of Labeling Technical Qs & As. In
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`addition, representative container or carton labeling, whichever includes Drug Facts,
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`(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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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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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` 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: 5367316
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` NDA 218424
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` Page 3
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`If you have any questions, contact Michael Boblitz, PharmD, Senior Regulatory Health
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`Project 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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`Pamela Horn, M.D.
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`Division Director
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`Division of Nonprescription Drugs II
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`Office of Nonprescription Drugs
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`Office of New Drugs
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
` Carton and Container 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: 5367316
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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.
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`/s/
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`PAMELA J HORN
`04/19/2024 12:17:09 PM
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`Reference ID: 5367316
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