`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
