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` NDA 206276/S-005
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` SUPPLEMENT APPROVAL
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`Alcon Research, LLC
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`Attention: Vincent Nanevie, MS, MBA, RAC
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`Director, Global Regulatory Affairs - Vision Care
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`6201 South Freeway
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`Fort Worth, TX 76134-2099
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`Dear Mr. Nanevie:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`September 13, 2019 and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Pataday Once Daily Relief
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`(olopatadine hydrochloride ophthalmic solution, 0.7%).
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`This “Prior Approval” supplemental new drug application provides for the full
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`prescription to over-the-counter switch of olopatadine hydrochloride 0.7% ophthalmic
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`solution.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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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
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` must be in the “Drug Facts” format (21 CFR 201.66), where applicable.
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` Submitted Draft Labeling
` Pataday® Once Daily Relief (Extra Strength)
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` 2.5 mL (0.085 Fl oz) 0.7% carton
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` Pataday® Once Daily Relief (Extra Strength)
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` 2.5 mL (0.085 Fl oz) 0.7% immediate
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` container
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` Pataday® Once Daily Relief (Extra Strength)
` Two X 2.5 mL (0.085 Fl oz) 0.7% carton ­
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` Twin Pack
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` Pataday® Once Daily Relief (Extra Strength)
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` Sample 0.5 mL (0.017 Fl oz) 0.7% carton
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` Date Submitted
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` July 9, 2020
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` June 25, 2020
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` July 9, 2020
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` July 9, 2020
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`Reference ID: 4640163
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`

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` NDA 206276/S-005
` Page 2
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` June 25, 2020
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` June 25, 2020
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` Pataday® Once Daily Relief (Extra Strength)
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` Sample 0.5 mL (0.017 Fl oz) 0.7% immediate
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` container
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` Pataday® Once Daily Relief (Extra Strength)
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` Sample 0.5 mL (0.017 Fl oz) 0.7% pouch
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` The FPL should be submitted electronically according to the guidance for industry
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` Providing Regulatory Submissions in Electronic Format — Certain Human
` Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications.1 For administrative purposes, designate this submission “Final Printed
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` Labeling for approved NDA 206276/S-005.” Approval of this submission by FDA is not
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`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
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`electronically, via the FDA automated system for processing structured product labeling
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`(SPL) files (eLIST). At the time that you submit your final printed labeling (FPL), the
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`content of labeling (Drug Facts) should be submitted in SPL format as described at
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`FDA.gov.2 Information on submitting SPL files using eLIST may be found in the
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`guidance for industry SPL Standard for Content of Labeling Technical Qs and As. In
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`addition, representative container or carton labeling, whichever includes Drug Facts,
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`(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
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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` 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.
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` 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4640163
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`

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` NDA 206276/S-005
` Page 3
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` REPORTING REQUIREMENTS
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` We remind you that you must comply with reporting requirements for an approved NDA
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` (21 CFR 314.80 and 314.81).
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`POSTMARKETING COMMITMENT
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` As part of an Enhanced Pharmacovigilance Commitment, for a period of 3 years, submit
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` as 15-day alert reports, all initial and follow-up postmarketing adverse event reports of
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` nonprescription overuse and nonprescription misuse from all postmarketing sources,
` including consumer reports, solicited reports, foreign reports, and clinical study reports.
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` As part of the periodic safety reports, provide a summary analysis of nonprescription
` overuse and nonprescription misuse adverse events, from postmarketing reports and
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` those published in the medical literature, as well as a cumulative summary of these
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`events.
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` If you have any questions, call LCDR Jung Lee, Safety Regulatory Project Manager, at
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` (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
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`Acting Deputy Director
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`Office of Nonprescription Drugs
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`Acting Director
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`Division of Nonprescription Drugs I
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`Office of New Drugs
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Carton and Container Labeling
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4640163
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`

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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/
`------------------------------------------------------------
`
`KAREN M MAHONEY
`07/13/2020 08:19:30 PM
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`Reference ID: 4640163
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`(
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