`
`NDA 020485/S-013
`
`Johnson & Johnson Consumer Inc.,
`McNeil Consumer Healthcare Division
`Attention: Jennifer Norman, RPh
`Director, Regulatory Affairs
`7050 Camp Hill Road
`Mail Stop 111
`Fort Washington, PA 19034-2299
`
`Dear Ms. Norman:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your supplemental New Drug Application (sNDA) dated and received December
`20, 2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Visine (naphazoline hydrochloride 0.025% and pheniramine maleate
`0.3%) ophthalmic solution.
`
`This “Prior Approval” supplemental new drug application provides for the following changes to
`the Principal Display Panel:
`
`• Changes the proprietary name from Visine®-A to Visine®
`• Revises the established name within the Statement of Identity consistent with current
`USP drug product title to “naphazoline HCl and pheniramine maleate ophthalmic
`solution”
`• Changes the statement “Multi-Action Eye Allergy Relief” to “Allergy Eye Relief Multi-
`Action”
`• Adds the statement “Original Prescription Strength”
`• Changes the claim “Clinically proven to relieve itchy, red, allergy eyes” to “Clinically
`proven to relieve red, itchy eyes”
`• Changes the graphic/trade dress
`
`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 printed. The FPL must be identical to the labeling submitted on October 12, 2018 and
`must be in the “Drug Facts” format (21 CFR 201.66), where applicable as follows:
`
`Reference ID: 4336416
`
`Eye Therapies Exhibit 2059, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`NDA 020485/S-013
`Page 2
`
`SKU
`
`15 mL carton
`30 mL carton (two 15 mL immediate container
`bottles, “twin pack”)
`15 mL immediate container bottle (front label)
`15 mL immediate container bottle (back label)
`
`Date Submitted
`October 12, 2018
`October 12, 2018
`
`October 12, 2018
`October 12, 2018
`
`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
`for approved NDA 020485/S-013.” 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
`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.
`
`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: 4336416
`
`Eye Therapies Exhibit 2059, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`NDA 020485/S-013
`Page 3
`
`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: 4336416
`
`(
`
`Eye Therapies Exhibit 2059, 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
`10/17/2018
`
`Reference ID: 4336416
`
`Eye Therapies Exhibit 2059, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`