`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NDA 208144/S-011
`
`Bausch & Lomb, Inc.
`Attention: Shaun A. Mbithi
`Associate Director, Global Regulatory Affairs
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Dear Ms. Mbithi:
`
`SUPPLEMENT APPROVAL
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`March 25, 2020, and your amendment, 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 “Prior Approval” supplemental new drug application provides for the following:
`
`1. Alternate carton artwork for the multidose 2.5 mL and 7.5 mL fill size
`containers which include an additional carton color with the flag ‘DIFFERENT
`LOOK SAME PRODUCT”
`2. Addition of bottle opening directions on the bottle image of the carton
`3. Addition of ‘LARGE SIZE’ to the 7.5 mL fill size carton artwork
`4. Update to all artwork (bottle label and carton) with company name change
`
`APPROVAL & LABELING
`
`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 enclosed agreed-upon
`labeling.
`
`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 in the “Drug Facts” format (21 CFR
`201.66), where applicable and be identical to the following:
`
`Submitted Labeling
`
`Date Submitted
`
`2.5 mL trade carton – grey and purple
`
`March 25, 2020
`
`2.5 mL sample carton – grey
`
`March 25, 2020
`
`Reference ID: 4673932
`
`Eye Therapies Exhibit 2064, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`NDA 208144/S-011
`Page 2
`
`2.5 mL trade container – grey
`
`2.5 mL sample container – grey
`
`March 25, 2020
`
`March 25, 2020
`
`7.5 mL trade carton – grey and purple
`
`March 25, 2020
`
`7.5 mL trade container – grey
`
`2 x 7.5 mL multi-pack carton – original
`grey
`
`2 x 7.5 mL blister card multi-pack –
`original grey
`
`March 25, 2020
`
`March 25, 2020
`
`March 25, 2020
`
`The FPL should be submitted electronically according to the guidance for industry
`Providing Regulatory Submissions in Electronic Format — Certain Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications.1 For administrative purposes, designate this submission “Final Printed
`Labeling for approved NDA 208144/S-011.” Approval of this submission by FDA is not
`required before the labeling is used.
`
`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
`FDA.gov.2 Information on submitting SPL files using eLIST may be found in the
`guidance for industry SPL Standard for Content of Labeling Technical Qs and As. 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
`
`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.
`
`2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4673932
`
`Eye Therapies Exhibit 2064, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`NDA 208144/S-011
`Page 3
`
`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.
`
`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 Anna Thai, Regulatory Project Manager, at
`301-796-6533.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Karen Minerve Murry, MD, FACE
`Acting Deputy Director, Office of Nonprescription Drugs
`Acting Director, Division of Nonprescription Drugs I
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`• Carton and Container Labeling
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4673932
`
`Eye Therapies Exhibit 2064, 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
`09/23/2020 05:02:03 PM
`
`Reference ID: 4673932
`
`Eye Therapies Exhibit 2064, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`