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` NDA 208144/S-011
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` SUPPLEMENT APPROVAL
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`Bausch & Lomb, Inc.
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`Attention: Shaun A. Mbithi
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`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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`March 25, 2020, and your amendment, submitted pursuant to section 505(b)(2) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Lumify (brimonidine tartrate
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`ophthalmic solution), 0.025%.
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`This “Prior Approval” supplemental new drug application provides for the following:
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` Submitted Labeling
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` 2.5 mL trade carton – grey and purple
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` 2.5 mL sample carton – grey
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` March 25, 2020
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` March 25, 2020
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`Reference ID: 4673932
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`1. Alternate carton artwork for the multidose 2.5 mL and 7.5 mL fill size
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`containers which include an additional carton color with the flag ‘DIFFERENT
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`LOOK SAME PRODUCT”
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`2. Addition of bottle opening directions on the bottle image of the carton
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`3. Addition of ‘LARGE SIZE’ to the 7.5 mL fill size carton artwork
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`4. Update to all artwork (bottle label and carton) with company name change
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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 in the “Drug Facts” format (21 CFR
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` 201.66), where applicable and be identical to the following:
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` Date Submitted
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` March 25, 2020
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` March 25, 2020
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` March 25, 2020
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` March 25, 2020
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` March 25, 2020
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` March 25, 2020
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` NDA 208144/S-011
` Page 2
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` 2.5 mL trade container – grey
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` 2.5 mL sample container – grey
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` 7.5 mL trade carton – grey and purple
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` 7.5 mL trade container – grey
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` 2 x 7.5 mL multi-pack carton – original
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` grey
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` 2 x 7.5 mL blister card multi-pack –
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` original grey
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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
` Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications.1 For administrative purposes, designate this submission “Final Printed
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` Labeling for approved NDA 208144/S-011.” 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 and 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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` 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
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4673932
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` NDA 208144/S-011
` Page 3
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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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`requirement.
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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, call Anna Thai, Regulatory Project Manager, at
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`301-796-6533.
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`Sincerely,
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`{See appended electronic signature page}
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`Karen Minerve Murry, MD, FACE
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`Acting Deputy Director, Office of Nonprescription Drugs
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`Acting Director, Division of Nonprescription Drugs I
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• 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: 4673932
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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/
`------------------------------------------------------------
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`KAREN M MAHONEY
`09/23/2020 05:02:03 PM
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`Reference ID: 4673932
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