( ~ DEPARTMENT OF HEALIB AND HUMAN SERVICES
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`Food and Drug Administrntion
`Silver Sp1ing MD 20993
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`SUPPLElVIENT APPROVAL
`
`NDA 208144/S-001
`
`Bausch + Lomb
`Attention: Shaun A. Mbithi
`Senior Manager, Regulato1y Affairs
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Dear Ms. Mbithi:
`
`Please refer to your supplemental New Drng Application (sNDA) dated and received May 18,
`2018, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Dmg,
`and Cosmetic Act (FDCA) for Lumify (brimonidine tartrate ophthalmic solution, 0.025%).
`
`We acknowledge receipt of your amendment dated and received November 2, 2018, which
`constituted a resubmission following our Refusal to File letter dated July 17, 2018.
`
`roval" SUEIJlemental new dm aEIJlication IJrovides for the addition of a 0.4 mL
`This "Prior A
`1
`h th
`.
`.
`fiill
`(l>JF"l .
`s1ze _;.--.----.-------.---..---.---..--- m an a Uilllllum pouc ; e
`addition of a dmg product manufacturing, packaging, release testing and stability testing site at
`(bJ <41• and the addition of contract laboratories
`(b>C4I
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`- - -
`to perfo1m
`.-----------------------
`analytical testing.
`
`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.
`
`LABELING
`
`Submit final printed labeling (FPL), as soon as they are available, but no more than 30 days after
`they are p1inted. The FPL must be identical to the submitted labeling and must be in the "Dmg
`Facts" fmmat (21 CFR 201.66), where applicable.
`
`Reference ID: 4394303
`
`Eye Therapies Exhibit 2061, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`NDA 208144/S-001
`Page 2
`
`Submitted Draft Labeling
`0.4 mL (single dose) foil pouch (sample) – updated to
`remove the gray color from the seal area
`0.4 mL (single dose) carton (sample)
`0.4 mL (single dose) vial (sample and trade)
`Coupon (Save $2.00 on 7.5 mL size)
`0.4 mL (single dose) foil pouch (trade)
`0.4 mL (single dose) carton (trade)
`
`Date Submitted
`November 2, 2018
`
`May 18, 2018
`May 18, 2018
`May 18, 2018
`January 22, 2019
`January 22, 2019
`
`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-001.” Approval of this submission by FDA is not required before
`the labeling is used.
`
`Remove the “New Product” text from the principal display panel 6 months after introduction into
`the marketplace.
`
`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 (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.
`
`Because none of these criteria apply to your application, you are exempt from this requirement.
`
`Reference ID: 4394303
`
`Eye Therapies Exhibit 2061, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`NDA 208144/S-001
`Page 3
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`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
`
`ENCLOSURE(S):
`Carton and Container Labeling
`
`Reference ID: 4394303
`
`Eye Therapies Exhibit 2061, 3 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`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/
`------------------------------------------------------------
`
`KAREN M MAHONEY
`02/21/2019 12:00:00 AM
`
`Reference ID: 4394303
`
`(
`
`
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`Eye Therapies Exhibit 2061, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`