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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 208144/S-002
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Bausch Health
`Attention: Shaun A. Mbithi
`Senior Manager, Regulatory Affairs
`400 Somerset Corporate Boulevard
`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 November
`20, 2018, 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%.
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`This “Prior Approval” supplemental new drug application provides for a new package
`configuration consisting of two 7.5 mL bottles packaged in a new multi-pack carton and blister
`card.
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`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.
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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 days after
`they are printed. The FPL must be identical to the submitted labeling and must be in the “Drug
`Facts” format (21 CFR 201.66), where applicable.
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`Submitted Draft Labeling
`2 x 7.5 mL multi-pack carton
`2 x 7.5 mL multi-pack blister card
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`Date Submitted
`April 19, 2019
`April 19, 2019
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`Reference ID: 4426355
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`NDA 208144/S-002
`Page 2
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`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 (April 2017,
`Revision 4). For administrative purposes, designate this submission “Final Printed Labeling
`for approved NDA 208144/S-002.” Approval of this submission by FDA is not 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
`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.
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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 new
`active ingredients (which includes new salts and new fixed combinations), 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 in pediatric
`patients unless this requirement is waived, deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this 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
`(21 CFR 314.80 and 314.81).
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`Reference ID: 4426355
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`NDA 208144/S-002
`Page 3
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`If you have any questions, call Jung Lee, Regulatory Project Manager, at (301) 796-3599.
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`Sincerely,
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`{See appended electronic signature page}
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`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 Blister Card Labeling
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`Reference ID: 4426355
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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
`04/30/2019 02:47:40 PM
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`Reference ID: 4426355
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