CENTER FOR DRUG EVALUATION AND RESEARCH
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`Approval Package for:
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`APPLICATION NUMBER:
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`208144Orig1s000
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` Lumify ophthalmic solution, 0.025%.
`
`brimonidine tartrate
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`
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`Trade Name:
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`Generic or Proper
`Name:
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`Sponsor:
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`
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`Approval Date:
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`Indication:
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`Bausch + Lomb
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`December 22, 2017
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`Lumify ophthalmic solution is indicated for the relief of
`redness of the eye due to minor eye irritations.
`
`
`

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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`208144Orig1s000
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`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
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`X
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`X
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`X
`X
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`X
`X
`X
`X
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`X
`X
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`X
`X
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`

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`CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`
`
`APPLICATION NUMBER:
`208144Orig1s000
`
`
`APPROVAL LETTER
`
`

`

`
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`
`
`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 208144
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`NDA APPROVAL
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`
`
`Bausch + Lomb
`Attention: Shaun A. Mbithi
`Senior Manager, Regulatory Affairs
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`
`Dear Ms. Mbithi:
`
`Please refer to your New Drug Application (NDA) dated February 27, 2017, received February
`27, 2017, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for Lumify (brimonidine tartrate) ophthalmic solution, 0.025%.
`
`This new drug application provides for the use of Lumify (brimonidine tartrate) ophthalmic
`solution for the relief of redness of the eye due to minor eye irritations.
`
`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 agreed-upon labeling text.
`
`We remind you that adequate data have not been submitted to support claims of
` We also remind you that the Drug Facts labeling states that consumers are to stop use of
`this product if the consumer’s condition worsens or persists for more than three days.
`
`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 submitted on
`December 20, 2017 and must be in the “Drug Facts” format (21 CFR 201.66), where applicable:
`
`
`Submitted Labeling
`2.5 mL carton – Sample and Trade
`7.5 mL carton - Sample and Trade
`2.5 mL container label – Sample and Trade
`7.5 mL container label – Sample and Trade
`
`The FPL should be submitted electronically according to the guidance for industry titled
`Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical
`Product Applications and Related Submissions Using the eCTD Specifications (May 2015,
`Revision 3). For administrative purposes, designate this submission “Final Printed Labeling
`
`Date Submitted
`December 20, 2017
`December 20, 2017
`December 20, 2017
`December 20, 2017
`
`Reference ID: 4199752
`
`(b) (4)
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`

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`NDA 208144
`Page 2
`
`
`for approved NDA 208144.” 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. 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.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`We are waiving the pediatric study requirement for ages 0 to 4 years because the product does
`not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in this
`age group and is not likely to be used in a substantial number of pediatric patients in this group.
`
`We note that you have fulfilled the pediatric study requirement for ages 5 to 17 years for this
`application.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`Reference ID: 4199752
`
`

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`NDA 208144
`Page 3
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`If you have any questions, call Jung Lee, Regulatory Project Manager, at (301) 796-3599.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Karen Murry Mahoney, MD, FACE
`Deputy Director
`Division of Nonprescription Drug Products
`Office of Drug Evaluation IV
`Center for Drug Evaluation and Research
`
`
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`ENCLOSURE(S):
`Carton and Container Labeling
`
`
`Reference ID: 4199752
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`KAREN M MAHONEY
`12/22/2017
`
`Reference ID: 4199752
`
`